Adapalene Gel 0.1% Acne Treatment

Adapalene Gel 0.1% Acne Treatment
SPL v2
SPL
SPL Set ID 22824b46-53a1-6b19-e063-6394a90a18ad
Route
TOPICAL
Published
Effective Date 2024-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Adapalene (0.1 g)
Inactive Ingredients
Carbomer 980 Benzyl Alcohol Poloxamer 124 Edetate Disodium Propylene Glycol Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-09-30

Description

Adapalene (retinoid) 0.1%

Indications and Usage

Adapalene is a topical retinoid used for treating acne vulgaris

Purpose

Acne Treatment

Dosage and Administration

Apply a thin film of Adapalene Gel, 0.1% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. For topical use only. Not for ophthalmic, oral or intravaginal use.


Medication Information

Indications and Usage

Adapalene is a topical retinoid used for treating acne vulgaris

Purpose

Acne Treatment

Dosage and Administration

Apply a thin film of Adapalene Gel, 0.1% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.

For topical use only. Not for ophthalmic, oral or intravaginal use.

Description

Adapalene (retinoid) 0.1%

Uses

For the treatment of acne

Section 43683-2

Added description for indications and usage

Warnings

For external use only

Directions

Adults and children 2 years 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 results 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
Active Ingredient

Adapalene (retinoid) 0.1%

Other Information
  • Store at USP controlled room temperature 20 - 25 0 C (68 - 77 0F)
  • protect from freezing
Inactive Ingredients

Inactive ingredients:

Carbopol 980, edetate disodium, benzyl alcohol, Poloxamer 124, Propylene Glycol, Purified Water, Sodium Hydroxide

Principal Display Panel

Carton Label - NDC 73715-003-01



Adapalene Gel, 0.1%

For external use only

Once daily Topical Acne Treatment

Net Wt 1 oz (30 grams)

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 irritation that becomes severe
  • irritation (redness, itching, dryness, burning) is more likely to occur
  • in the first few weeks of use
  • if using more 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 area with water
  • wash hands after use
Stop Use and Ask A Doctor If
  • you become pregnant, or are 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
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses (USES)

For the treatment of acne

Section 43683-2 (43683-2)

Added description for indications and usage

Purpose (PURPOSE)

Acne Treatment

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)

Adults and children 2 years 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 results 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
Active Ingredient (ACTIVE INGREDIENT)

Adapalene (retinoid) 0.1%

Other Information (OTHER INFORMATION)
  • Store at USP controlled room temperature 20 - 25 0 C (68 - 77 0F)
  • protect from freezing
Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients:

Carbopol 980, edetate disodium, benzyl alcohol, Poloxamer 124, Propylene Glycol, Purified Water, Sodium Hydroxide

Indications and Usage (INDICATIONS AND USAGE)

Adapalene is a topical retinoid used for treating acne vulgaris

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Carton Label - NDC 73715-003-01



Adapalene Gel, 0.1%

For external use only

Once daily Topical Acne Treatment

Net Wt 1 oz (30 grams)

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 irritation that becomes severe
  • irritation (redness, itching, dryness, burning) is more likely to occur
  • in the first few weeks of use
  • if using more 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 area with water
  • wash hands after use
Dosage and Administration (DOSAGE AND ADMINISTRATION)

Apply a thin film of Adapalene Gel, 0.1% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.

For topical use only. Not for ophthalmic, oral or intravaginal use.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)
  • you become pregnant, or are 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
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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Raw Label Data

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