ADAPALENE ADAPALENE TARGET CORPORATION FDA Approved Use For the treatment of acne
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Substance Adapalene
Route
TOPICAL
Applications
ANDA215940
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Adapalene USP 0.1% (retinoid) read consumer information leaflet
Inactive Ingredients
Inactive ingredients carbomer homopolymer type C edetate disodium phenoxyethanol poloxamer 182 propylene glycol purified water sodium hydroxide.
Strengths
0.1 %
Treats Conditions
Use For The Treatment Of Acne

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0382442105018
UNII
1L4806J2QF
Packaging

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Adapalene Gel USP, 0.1% Acne Treatment Previously available by prescription only Once daily topical retinoid* FDA approved Dermatologist Tested up&up ™ *Read consumer information leaflet before use NET WT 0.5 OZ (15 g) Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Adapalene Gel USP, 0.1% Acne Treatment Previously available by prescription only Once daily topical retinoid* FDA approved Dermatologist Tested up&up ™ *Read consumer information leaflet before use NET WT 0.5 OZ (15 g) Carton

Overview

Use For the treatment of acne

Indications & Usage

Use For the treatment of acne

Dosage & Administration

Directions Adults and children 12 years of age and older: use once daily clean the skin gently and pat dry before applying the product cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face. do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation. Children under 12 years of age: ask a doctor

Warnings & Precautions
Warnings For external use only Do not use on damaged skin (cuts, abrasions, eczema, sunburn) if you are allergic to adapalene or any of the ingredients in this product. If pregnant or breast-feeding, ask a doctor before use. When using this product limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors do not wax to remove hair in areas where the product has been applied during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe irritation (redness, itching, dryness, burning) is more likely to occur: in the first few weeks of use if using more than one topical acne medication at a time but irritation usually lessens with continued use of this product it may take up to 3 months of once daily use to see results avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water. wash hands after use Stop use and ask doctor if you become pregnant, or are planning to become pregnant, while using the product you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) irritation becomes severe you see no improvement after 3 months of once daily use Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Acne treatment

Do Not Use

Do not use on damaged skin (cuts, abrasions, eczema, sunburn) if you are allergic to adapalene or any of the ingredients in this product.

When Using

When using this product limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors do not wax to remove hair in areas where the product has been applied during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe irritation (redness, itching, dryness, burning) is more likely to occur: in the first few weeks of use if using more than one topical acne medication at a time but irritation usually lessens with continued use of this product it may take up to 3 months of once daily use to see results avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water. wash hands after use

Stop Use & Ask a Doctor

Stop use and ask doctor if you become pregnant, or are planning to become pregnant, while using the product you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) irritation becomes severe you see no improvement after 3 months of once daily use

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Storage & Handling

Other information TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE. store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. protect from freezing

Questions

Questions? 1-800-910-6874


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