Adapalene Gel Usp 0 1 Percent Ene 0 5

Adapalene Gel Usp 0 1 Percent Ene 0 5
SPL v5
SPL
SPL Set ID a9816181-d643-4579-8b12-3927120dc627
Route
TOPICAL
Published
Effective Date 2024-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Adapalene (1 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetate Disodium Methylparaben Poloxamer 182 Propylene Glycol Water Sodium Hydroxide Hydrochloric Acid

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-01-31

Description

Adapalene, USP 0.1% (retinoid)* *read consumer information leaflet

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Adapalene, USP 0.1% (retinoid)* *read consumer information leaflet

Use
  • For the treatment of acne
Warnings

For external use only

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 in 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

Do Not Use
  • on damaged skin (cuts, abrasions eczema, sunburn)
  • if you are allergic to adapalene or any of the ingredients in this product
Product Label
SIGNATURE SELECT Acne Treatment
Active Ingredient

Adapalene, USP 0.1% (retinoid)*

*read consumer information leaflet

Other Information
  • store at rooms temperature 68º to 77ºF
  • protect from freezing
Inactive Ingredients

carbomer homopolymer type C, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water

May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO Differin® Gel active ingredient**

ADAPALENE GEL USP 0.1%

ACNE TREATMENT

  • Previously available only by prescription
  • Once daily topical retinoid*
  • Oil free
  • fragrance free

NET WT OZ (g)

*Read consumer information leaflet before use

*Read carton and enclosed consumer information leaflet before using this product. Keep this carton and consumer information leaflet. They contain important information.

**This product is not manufactured or distributed by Galderma Laboratories, L.P., distributor of Differin® Gel.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

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 become 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 month. If contact occurs immediately flush the area with water.
  • wash hands after use
Stop Use and Ask A Doctor If
  • you become pregnant, or planning to become pregnant while using this 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
If Pregnant Or Breast Feeding,

ask a doctor before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Use
  • For the treatment of acne
Purpose

Acne treatment

Warnings

For external use only

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 in 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

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
Product Label
SIGNATURE SELECT Acne Treatment
Active Ingredient (Active ingredient)

Adapalene, USP 0.1% (retinoid)*

*read consumer information leaflet

Other Information (Other information)
  • store at rooms temperature 68º to 77ºF
  • protect from freezing
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type C, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water

May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO Differin® Gel active ingredient**

ADAPALENE GEL USP 0.1%

ACNE TREATMENT

  • Previously available only by prescription
  • Once daily topical retinoid*
  • Oil free
  • fragrance free

NET WT OZ (g)

*Read consumer information leaflet before use

*Read carton and enclosed consumer information leaflet before using this product. Keep this carton and consumer information leaflet. They contain important information.

**This product is not manufactured or distributed by Galderma Laboratories, L.P., distributor of Differin® Gel.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA 94566-0009

When Using This Product (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 become 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 month. If contact occurs immediately flush the area with water.
  • wash hands after use
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you become pregnant, or planning to become pregnant while using this 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
If Pregnant Or Breast Feeding, (If Pregnant or breast-feeding,)

ask a doctor before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


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Raw Label Data

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