Neutrogena Adapalene Gel 0.1% Acne Treatment

Neutrogena Adapalene Gel 0.1% Acne Treatment
SPL v2
SPL
SPL Set ID 0682cb55-6ae3-437f-e063-6294a90ac510
Route
TOPICAL
Published
Effective Date 2023-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-12-04

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Drug Facts

Use

For the treatment of acne

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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 the eyes, lips, and mouth. If contact occurs, immediately flush the area with water.

▪ wash hands after use

Section 50570-1

Do not use

▪on damaged skin (cuts, abrasions, eczema, sunburn)

▪ if you are allergic to adapalene or any of the ingredients in this product

Section 53414-9

If pregnant or breast-feeding, ask a doctor before use.

Warnings

For external use only

Directions

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

Active Ingredient

Adapalene, USP 0.1% (retinoid)*

*read consumer information leaflet

Other Information

▪ store at room temperature 68° to 77°F

▪ protect from freezing

Inactive Ingredients

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

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

Questions Or Comments?

Call 800-582-4048; Outside US, dial collect

215-273-8755 or visit www.neutrogena.com

Principal Display Panel 45 G Tube Carton

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

NEW

Adapalene

Gel 0.1%

Acne Treatment

Previously available only

By prescription

Dermatologist developed

& tested

Once Daily Topical

Retinoid*

Oil Free

Fragrance Free

*Read consumer information

leaflet before use

NET WT 1.6 OZ (45 g)


Structured Label Content

Use

For the treatment of acne

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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 the eyes, lips, and mouth. If contact occurs, immediately flush the area with water.

▪ wash hands after use

Section 50570-1 (50570-1)

Do not use

▪on damaged skin (cuts, abrasions, eczema, sunburn)

▪ if you are allergic to adapalene or any of the ingredients in this product

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a doctor before use.

Purpose

Acne treatment

Warnings

For external use only

Directions

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

Active Ingredient (Active ingredient)

Adapalene, USP 0.1% (retinoid)*

*read consumer information leaflet

Other Information

▪ store at room temperature 68° to 77°F

▪ protect from freezing

Inactive Ingredients (Inactive ingredients)

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

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

Questions Or Comments? (Questions or comments?)

Call 800-582-4048; Outside US, dial collect

215-273-8755 or visit www.neutrogena.com

Principal Display Panel 45 G Tube Carton (PRINCIPAL DISPLAY PANEL - 45 g Tube Carton)

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

NEW

Adapalene

Gel 0.1%

Acne Treatment

Previously available only

By prescription

Dermatologist developed

& tested

Once Daily Topical

Retinoid*

Oil Free

Fragrance Free

*Read consumer information

leaflet before use

NET WT 1.6 OZ (45 g)


Advanced Ingredient Data


Raw Label Data

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