Adapalene Gel
FDA Label NDC 46122-768

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Adapalene (NDC 46122-768). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, do not use, otc - pregnancy or breast feeding, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed By AmerisourceBergen
1 West First Ave., Conshohocken
PA 19428

Active Ingredient

Adapalene USP, 0.1% (retinoid)

read consumer information leaflet

Purpose

Acne treatment

Use

  • For the treatment of acne

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Directions

Adults and children 12 years of age and older:

  • use oncedaily
  • 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

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

Inactive Ingredients

carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

Questions?

1-866-923-4914

Principal Display Panel - 15 G Tube Carton

NDC 46122-768-36

Compare to the
Differin ®Gel †
active ingredient

GOOD
NEIGHBOR
PHARMACY ®

PARABEN FREE

Adapalene
Gel USP, 0.1%
Acne Treatment

  • Previously available
    only by prescription
  • FDA approved
  • Dermatologist developed
  • Once Daily Topical Retinoid*

    • * Read consumer information
    leaflet before use

    NET WT
    0.5 oz (15 g)

    Principal Display Panel (15 g Tube Carton)

    Principal Display Panel (15 g Tube Carton)

* Please review the disclaimer below.