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

Purpose

Acne treatment

Description

Drug Facts


Medication Information

Warnings

For external use only

Purpose

Acne treatment

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

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.

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.

Active Ingredient

Adapalene, USP 0.1% (retinoid)*

*read consumer information leaflet

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

Warnings

For external use only

Purpose

Acne treatment

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

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.

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.

Active Ingredient (Active ingredient)

Adapalene, USP 0.1% (retinoid)*

*read consumer information leaflet

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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