Adapalene Gel 15g

Adapalene Gel 15g
SPL v3
SPL
SPL Set ID 0ce4684a-4733-e669-e063-6394a90a58c1
Route
TOPICAL
Published
Effective Date 2023-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Adapalene (0.00036 g)
Inactive Ingredients
Carbomer Homopolymer Type C

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2023-12-20

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

Section 51727-6

carbomer homopolymer, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water and sodium hydroxide

Section 51945-4

Warnings

For external use only

Directions

• 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. Adults and children 12 years of age and older:

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

Active Ingredient

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet

Other Information

store at room temperature 68º to 77ºF protect from freezing

Questions Or Comments

1-800-768-2913

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 A 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

If Pregnant Or Breast Feeding

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 right away


Structured Label Content

Use (USE)

for the treatment of acne

Section 51727-6 (51727-6)

carbomer homopolymer, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water and sodium hydroxide

Section 51945-4 (51945-4)

Purpose

.Acne treatment

Warnings

For external use only

Directions

• 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. Adults and children 12 years of age and older:

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

Active Ingredient

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet

Other Information (Other information)

store at room temperature 68º to 77ºF protect from freezing

Questions Or Comments (Questions or comments)

1-800-768-2913

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 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 A Doctor If (Stop use and ask a 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

If Pregnant Or Breast Feeding (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 right away


Advanced Ingredient Data


Raw Label Data

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