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Differin 0.1% Cream 45 Gm By Galderma Labs.

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Differin 0.1% Cream 45 Gm By Galderma Labs.

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Differin 0.1% Cream 45 Gm By Galderma Labs. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD2973774/RXB10055091/RXA391374
Size : 45 GM
Selling UoM : EA
NDC: 00299-5915-45
UPC Barcode : 302995915452
Supplier: 0050000496 GALDERMA LABS,INC.
Supplier Material : 591545
Generic Code : 031789 ADAPALENE TOPICAL CREAM (G) 0.1 %
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

During treatment with Differin? 0.1% dryness, erythema, burning or pruritus can occur. These side effects differ in frequency depending on the formulation used of Differin? 0.1% (cream vs. gel). During treatment with Differin? Gel 0.3% signs of cutaneous irritation like redness, scaling, dryness and/or stinging/burning may occur, but should be mild or moderate, occur early in treatment and decrease thereafter. Other side effects that may occur from using Differin? Gel 0.3% include skin discomfort, pruritus and sunburn.

Concomitant use of potentially irritating products or overexposure to sunlight or sunlamps, extreme wind or cold, may increase the potential for irritation from both product concentrations. Use of sunscreen and protective clothing is recommended.

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Product Insert Information
United States
DIFFERIN? (adapalene) Cream, 0.1%
For topical use only. Not for ophthalmic, oral, or intravaginal use.

DESCRIPTION: DIFFERIN? (adapalene) Cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine.

INDICATIONS AND USAGE: DIFFERIN? Cream is indicated for the topical treatment of acne vulgaris.


CONTRAINDICATIONS: DIFFERIN? Cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.

PRECAUTIONS: General: Certain cutaneous signs and symptoms of treatment such as erythema, dryness, scaling, burning, or pruritus may be experienced with use of DIFFERIN? Cream. These are most likely to occur during the first two to four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to reduce the frequency of application or discontinue use.

If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during use of adapalene. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene.

Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of waxing as a depilatory method should be avoided on skin treated with adapalene.

INFORMATION FOR PATIENTS: Patients using DIFFERIN? Cream should receive the following information and instructions:

1. This medication is to be used only as directed by the physician.
2. It is for external use only.
3. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.
4. Cleanse area with a mild or soapless cleanser before applying this medication.
5. Moisturizers may be used if necessary however, products containing alpha hydroxy or glycolic acids should be avoided.
6. Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis, and eye irritation.
7. This medication should not be applied to cuts, abrasions, eczematous or sunburned skin.
8. Wax epilation should not be performed on treated skin due to the potential for skin erosions.
9. During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of this medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Overall clinical benefit may be noticed after two weeks of therapy, but at least eight weeks are required to obtain consistent beneficial effects.