Tretinoin (Tretinoin)

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Trade Name: Tretinoin

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Spear Dermatology Products Inc

Presentation: CREAM, HUMAN PRESCRIPTION DRUG

Strength: 0.5 mg/g

Storage and handling

TRETINOIN Retinoid [EPC],Retinoids [CS]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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Tretinoin Cream and Tretinoin Gel are used for the topical treatment of acne vulgaris. Tretinoin Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose and alcohol (denatured with -butyl alcohol and brucine sulfate) 90% w/w. Tretinoin Cream contains tretinoin in either of three strengths, 0.1%, 0.05%, or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-retinoic acid and has the following structure:n

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

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The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin. To date, all adverse effects of tretinoin have been reversible upon discontinuance of therapy (see ).

If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

Tretinoin Cream or Tretinoin Gel should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Gel: Excessive application results in u201cpillingu201d of the gel, which minimizes the likelihood of over application by the patient.
Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment.
Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance.
During the early weeks of therapy, an exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy.
Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen.
Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms.
Patients treated with tretinoin acne treatment may use cosmetics, but the area to be treated should be cleansed thoroughly before the medication is applied. (see .)

Tretinoin is supplied as:

Tretinoin Gel, 0.025% and 0.01%: store below 86u00b0F.
Tretinoin Cream, 0.1%, 0.05%, and 0.025%: store below 80u00b0F.

Rx only
Manufactured for:
By:
Rev. 11/16

TRETINOIN CREAM
TRETINOIN GEL
Acne Treatment
PATIENT INSTRUCTIONS
For Topical Use Only
IMPORTANT
Read Directions Carefully Before Using
THIS LEAFLET TELLS YOU ABOUT TRETINOIN ACNE TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. THIS PRODUCT IS TO BE USED ONLY ACCORDING TO YOUR DOCTOR'S INSTRUCTIONS, AND IT SHOULD NOT BE APPLIED TO OTHER AREAS OF THE BODY OR TO OTHER GROWTHS OR LESIONS. THE LONG-TERM SAFETY AND EFFECTIVENESS OF THIS PRODUCT IN OTHER DISORDERS HAVE NOT BEEN EVALUATED. IF YOU HAVE ANY QUESTIONS, BE SURE TO ASK YOUR DOCTOR.
WARNINGS AND PRECAUTIONS
The effects of the sun on your skin.
Laboratory findings.n- When laboratory mice are exposed to artificial sunlight, they often develop skin tumors. These sunlight-induced tumors may appear more quickly and in greater number if the mouse is also topically treated with the active ingredient in Tretinoin Cream and Gel, tretinoin. In some studies, under different conditions, however, when mice treated with tretinoin were exposed to artificial sunlight, the incidence and rate of development of skin tumors was reduced. There is no evidence to date that tretinoin alone will cause the development of skin tumors in either laboratory animals or humans. However, investigations in this area are continuing.
Use caution in the sun.n- any time you are outside
Avoid excessive exposure to wind or cold.
Possible problems.
Use other medication only on your physician's advice.
Do not use other medications with tretinoin which are not recommended by your doctor. The medications you have used in the past might cause unnecessary redness or peeling.
If you are pregnant, think you are pregnant or are nursing an infant:
GELS ARE FLAMMABLE.
AND WHILE YOU'RE ON TRETINOIN THERAPY
Use a mild, non-medicated soap. Avoid frequent washings and harsh scrubbing.
HOW TO USE TRETINOIN
To get the best results with tretinoin therapy, it is necessary to use it properly. Forget about the instructions given for other products and the advice of friends. Just stick to the special plan your doctor has laid out for you and be patient. Remember, when tretinoin is , many users see improvement by 12 weeks. AGAIN, FOLLOW INSTRUCTIONS - BE PATIENT u2013 DON'T START AND STOP THERAPY ON YOUR OWN - IF YOU HAVE QUESTIONS, ASK YOUR DOCTOR.
To help you use the medication correctly, keep these simple instructions in mind.
WHAT TO EXPECT WITH YOUR NEW TREATMENT
Tretinoin works deep inside your skin and this takes time. You cannot make tretinoin work any faster by applying more than one dose each day, but an excess amount of tretinoin may irritate your skin. Be patient.
There may be some discomfort or peeling during the early days of treatment. Some patients also notice that their skin begins to take on a blush.
These reactions do not happen to everyone. If they do, it is just your skin adjusting to Tretinoin and this usually subsides within two to four weeks. These reactions can usually be minimized by following instructions carefully. Should the effects become excessively troublesome, consult your doctor.
BY THREE TO SIX WEEKS, some patients notice an appearance of new blemishes (papules and pustules). At this stage it is using tretinoin.
If tretinoin is going to have a beneficial effect for you, you should notice a continued improvement in your appearance after 6 to 12 weeks of therapy. Don't be discouraged if you see no immediate improvement. Don't stop treatment at the first signs of improvement.
Once your acne is under control you should continue regular application of tretinoin until your physician instructs otherwise.
IF YOU HAVE QUESTIONS
All questions of a medical nature should be taken up with your doctor.
Manufactured for:
By:
Rev. 11/16

SPEARDERMATOLOGY PRODUCTS
NDC
Tretinoin Cream, 0.025%
For Topical Use Onlyn- Usual Dosage: See package insert. Store below 80u00b0F
WARNING: Keep out of reach of children.
Rx onlyn- Net Wt. 45 g

SPEARn- DERMATOLOGY PRODUCTS
NDC
Tretinoin Cream, 0.05%
For Topical Use Onlyn- Usual Dosage: See package insert. Store below 80u00b0F.
WARNING: Keep out of reach of children.
Rx onlyn- Net Wt. 45 g

SPEARn- DERMATOLOGY PRODUCTS
Tretinoin Cream, 0.1%
NDC
For Topical Use Onlyn- Usual Dosage: See package insert. Store below 80u00b0F.n- WARNING: Keep out of reach of children.
Rx onlyn- Net Wt. 45 g

NDC
SPEAR n- DERMATOLOGY PRODUCTS
Tretinoin Gel, 0.01%
For Topical Use Only. n- Usual Dosage: See package insert. Store below 86u00b0F.
WARNING: Keep out of reach of children
Rx only
Net Wt. 45 g

SPEARn- DERMATOLOGY PRODUCTS
NDC
Tretinoin Gel 0.025%
For Topical Use Only.n- Usual Dosage: See package insert. Store below 86u00b0F.
WARNING: Keep out of reach of children.
Rx onlyn- Net Wt. 45 g

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Tretinoin (Tretinoin) which is also known as Tretinoin and Manufactured by Spear Dermatology Products Inc. It is available in strength of 0.5 mg/g.

Tretinoin (Tretinoin) 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.