Adapalene ADAPALENE GLENMARK THERAPEUTICS INC., USA FDA Approved Use • For the treatment of acne
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Substance Adapalene
Route
TOPICAL
Applications
ANDA091314

Drug Facts

Composition & Profile

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

Identifiers & Packaging

Container Type BOX
UPC
0372657158176 0372657158558
UNII
1L4806J2QF
Packaging

Package/Label Principal Display Panel NDC 72657-158-17 Adapalene Gel USP, 0.1% NET WT. 0.5 OZ (15 g) carton15g; Package/Label Principal Display Panel NDC 72657-158-55 Adapalene Gel USP, 0.1% NET WT. 1.6 OZ (45 g) carton45g

Package Descriptions
  • Package/Label Principal Display Panel NDC 72657-158-17 Adapalene Gel USP, 0.1% NET WT. 0.5 OZ (15 g) carton15g
  • Package/Label Principal Display Panel NDC 72657-158-55 Adapalene Gel USP, 0.1% NET WT. 1.6 OZ (45 g) carton45g

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 breastfeeding , 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: • 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
Purpose

Purpose Acne treatment

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.


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