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Tretinoin (Retin-A Micro)

Trade Name : Retin-A MICRO

Bausch Health US LLC

GEL

Strength 1 mg/g

TRETINOIN Retinoid [EPC],Retinoids [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tretinoin (Retin-A Micro) which is also known as Retin-A MICRO and Manufactured by Bausch Health US LLC. It is available in strength of 1 mg/g per ml. Read more

Tretinoin (Retin-A Micro) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Retin-A Micro is a retinoid indicated for topical application in the treatment of acne vulgaris.
  • Retin-A Micro is a retinoid, indicated for topical treatment of acne vulgaris. ()
  • For topical use only. Not for ophthalmic, oral, or intravaginal use.
  • Retin-A Micro should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area in a thin layer. Areas to be treated should be cleansed thoroughly before the medication is applied. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. A transitory feeling of warmth or slight stinging may be noted on application. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or the frequency of application increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies.
  • During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. If tolerated, this should not be considered a reason to discontinue therapy [see ].
  • Therapeutic results may be noticed after two weeks, but more than seven weeks of therapy are required before consistent beneficial effects are observed.
  • Retin-A Micro should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes.
  • Patients treated with Retin-A Micro may use cosmetics.
  • Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin. Avoid contact with the peel of limes. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with Retin-A Micro. It also is advisable to allow the effects of such preparations to subside before use of Retin-A Micro is begun.
  • Retin-A Micro is a white to very pale yellow opaque gel. Retin-A Micro is available in four strengths: 0.1%, 0.08%, 0.06% and 0.04%.
  • Each gram of Retin-A Micro Gel, 0.1%, contains 1 mg of tretinoin.
  • Each gram of Retin-A Micro Gel, 0.08%, contains 0.8 mg of tretinoin.
  • Each gram of Retin-A Micro Gel, 0.06%, contains 0.6 mg of tretinoin.
  • Each gram of Retin-A Micro Gel, 0.04%, contains 0.4 mg of tretinoin.
  • Gel, 0.1%, 0.08%, 0.06%, and 0.04% ()
  • None.
  • None. ()
  • No data
  • ,
  • Most common adverse reactions are skin pain, pruritus, skin irritation/subcutaneous irritation, pharyngitis, and erythema. n
  • u00a0To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Retin-A Micro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant and nursing women. n
  • Oral ingestion of large amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
  • Retin-A Micro (tretinoin) Gel microsphere, 0.1%, 0.08%, 0.06% and 0.04% is a white to very pale yellow opaque gel for topical treatment of acne vulgaris.
  • Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of CHO and the following chemical structure:
  • Each gram of Retin-A Micro Gel, 0.1%, contains 1 mg of tretinoin.
  • Each gram of Retin-A Micro Gel, 0.08%, contains 0.8 mg of tretinoin.
  • Each gram of Retin-A Micro Gel, 0.06%, contains 0.6 mg of tretinoin.
  • Each gram of Retin-A Micro Gel, 0.04%, contains 0.4 mg of tretinoin.
  • The formulation uses methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. Other components consist of benzyl alcohol, butylated hydroxytoluene, carbomer 974P, cyclomethicone and dimethicone copolyol, disodium EDTA, glycerin, PPG-20 methyl glucose ether distearate, propylene glycol, purified water, sorbic acid, and trolamine.
  • No data
  • Dermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin) Gel microsphere, 0.1%, 0.08%, 0.06% or 0.04%.
  • In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of the 0.04% and 0.1% clinical formulations. A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day tretinoin, respectively. These doses are two and four times the MRHD based on BSA comparison.
  • The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice.
  • There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the MRHD based on BSA comparison).
  • Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources [see ].
  • The genotoxic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative.
  • The components of the microspheres have shown potential for genetic toxicity and fetal malformation. EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, and the in vivo mouse micronucleus assay.
  • In oral fertility studies in rats with tretinoin, the no-observable effect level was 2 mg/kg/day (19 times the MRHD based on BSA comparison).
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • The patient should be instructed to:
  • Cleanse the treatment area thoroughly, before treatment, with a mild, non-medicated cleanser. Do not use more than the recommended amount and do not apply Retin-A Micro more than once daily as this will not produce faster or better results, but may increase irritation.
  • Minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.
  • Manufactured for:
  • Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA
  • By:
  • Valeant Pharmaceuticals International, Inc.
  • Laval, Quebec H7L 4A8, Canada
  • Retin-A Micro is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
  • Microsponge is a registered trademark of AMCOL International Corporation. Any other product/brand names are trademarks of their respective owners.
  • u00a9Valeant Pharmaceuticals North America LLC
  • 9612500 20002065A
  • Retin-A Micro (ret-in-A MY-kroe)n- (tretinoin) Gel microsphere, 0.1%, 0.08%, 0.06%, and 0.04%n- for topical use
  • Important information:
  • What is Retin-A Micro?
  • Retin-A Micro
  • It is not known if Retin-A Micro is safe and effective in the treatment of other conditions.
  • It is not known if Retin-A Micro is safe and effective in children under 12 years of age.
  • What should I tell my doctor before using Retin-A Micro?
  • Before using Retin-A Micro, tell your doctor about all of your medical conditions, including if you:
  • Tell your doctor about all of the medicines you take,
  • Especially tell your doctor if you use any other medicines to treat your acne, including medicated cleansers or soaps. Using other topical acne products may increase the irritation of your skin when used with Retin-A Micro.
  • Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
  • How should I use Retin-A Micro?
  • Arrayn- Applying Retin-A Micro
  • Tube:
  • Pump:
  • What should I avoid while using Retin-A Micro?
  • What are the possible side effects of Retin-A Micro?
  • Retin-A Micro may cause serious side effects, including:
  • Skin irritation.
  • The most common side effects of Retin-A Micro include
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of Retin-A Micro. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Retin-A Micro?
  • Keep Retin-A Micro and all medicines out of the reach of children.
  • General information about the safe and effective use of Retin-A Micro.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Retin-A Micro for a condition for which it was not prescribed. Do not give Retin-A Micro to other people, even if they have the same symptoms you have. It may harm them.
  • If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Retin-A Micro that is written for health professionals.
  • For more information, call 1-800-321-4576.
  • What are the ingredients of Retin-A Micro?
  • Active ingredient:
  • Inactive ingredients:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:
  • Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA
  • By:
  • Valeant Pharmaceuticals International, Inc.
  • Laval, Quebec H7L 4A8, Canada
  • Retin-A Micro is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
  • Microsponge is a registered trademark of AMCOL International Corporation. Any other product/brand
  • names are trademarks of their respective owners.
  • u00a9 Valeant Pharmaceuticals North America LLC
  • 9612500 20002065A
  • Revised - 10/2017
  • NDC
  • Arrayn- (tretinoin) Gel microspheren- Array
  • Arrayn- PUMP
  • For Topical Use Onlyn- Rx Only
  • VALEANT
  • NET WT. 50 g
  • NDC
  • Arrayn- (tretinoin) Gel microspheren- Array
  • Arrayn- PUMP
  • For Topical Use Onlyn- Rx only
  • VALEANT
  • NET WT. 50 g
  • NDC
  • Arrayn- (tretinoin gel) microspheren- Array
  • Arrayn- PUMP
  • For Topical Use Onlyn- Rx Only
  • VALEANT
  • Net Wt
  • NDC
  • Arrayn- (tretinoin gel) microspheren- 0.1%
  • Arrayn- PUMP
  • For Topical Use Onlyn- Rx Only
  • VALEANT
  • Net Wt

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