Acne Gel Pen

Acne Gel Pen
SPL v1
SPL
SPL Set ID 4176d9b1-ca93-a6c4-e063-6394a90a68fb
Route
TOPICAL
Published
Effective Date 2025-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Zingiber Officinale (ginger) Root Oil Niacinamide Sodium Hydroxide Melia Azadirachta Leaf Pvp Water Phenoxyethanol Glycerin Hamamelis Virginiana Leaf Water T-butyl Alcohol Azadirachta Indica Flower Alcohol Bisabolol Ethylhexylglycerin Centella Asiatica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-31

Description

Keep out of reach of children ■ if swallowed, get medical help or contact a Poison Control Center right away


Medication Information

Warnings and Precautions

Warnings

■ For External Use Only

When using this product ■ skin irritation

and dryness is more likely to occur if you

use another topical acne medication at the

same time. If irritation occurs, only use one

topical acne medication at a time.

Do not use if you ■ have very sensitive

skin ■ are sensitive to salicylic acid

Stop use and ask a doctor if irritation

becomes severe

Keep out of reach of children

■ if swallowed, get medical help or contact

a Poison Control Center right away

Flammable: Keep away from high heat

and flame

Indications and Usage

Uses ■ For the management of acne

Dosage and Administration

Directions ■ Twist bottom of pen to

release liquid. Apply liquid directly on

individual blemishes or clusters ■ Clean

the skin thoroughly before applying this

product ■ Cover the entire affected area

with a thin layer one to three times daily

■ Because excessive drying of the skin

may occur, start with one application daily,

then gradually increase to two or three

times daily if needed or as directed by a

doctor ■ If bothersome dryness or peeling

occurs, reduce application to once a day or

every other day

Description

Keep out of reach of children ■ if swallowed, get medical help or contact a Poison Control Center right away

Section 50565-1

Keep out of reach of children

■ if swallowed, get medical help or contact

a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if irritation

becomes severe.

Section 51727-6

Inactive Ingredients:

Alcohol Denat., Hamamelis Virginiana (Witch

Hazel) Water, Polyvinylpyrrolidone, Alcohol,

Niacinamide, Water/Aqua/Eau, Sodium

Hydroxide, Phenoxyethanol, Melia

Azadirachta Leaf Extract, Bisabolol, Glycerin,

t-Butyl Alcohol, Melia Azadirachta Flower

Extract, Ethylhexylglycerin, Centella Asiatica

Extract, Zingiber Officinale (Ginger) Root

Extract

Section 51945-4

Section 55105-1

Purpose.......Acne Treatment

Section 55106-9

Salicylic Acid 2%


Structured Label Content

Indications and Usage (34067-9)

Uses ■ For the management of acne

Dosage and Administration (34068-7)

Directions ■ Twist bottom of pen to

release liquid. Apply liquid directly on

individual blemishes or clusters ■ Clean

the skin thoroughly before applying this

product ■ Cover the entire affected area

with a thin layer one to three times daily

■ Because excessive drying of the skin

may occur, start with one application daily,

then gradually increase to two or three

times daily if needed or as directed by a

doctor ■ If bothersome dryness or peeling

occurs, reduce application to once a day or

every other day

Warnings and Precautions (34071-1)

Warnings

■ For External Use Only

When using this product ■ skin irritation

and dryness is more likely to occur if you

use another topical acne medication at the

same time. If irritation occurs, only use one

topical acne medication at a time.

Do not use if you ■ have very sensitive

skin ■ are sensitive to salicylic acid

Stop use and ask a doctor if irritation

becomes severe

Keep out of reach of children

■ if swallowed, get medical help or contact

a Poison Control Center right away

Flammable: Keep away from high heat

and flame

Section 50565-1 (50565-1)

Keep out of reach of children

■ if swallowed, get medical help or contact

a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation

becomes severe.

Section 51727-6 (51727-6)

Inactive Ingredients:

Alcohol Denat., Hamamelis Virginiana (Witch

Hazel) Water, Polyvinylpyrrolidone, Alcohol,

Niacinamide, Water/Aqua/Eau, Sodium

Hydroxide, Phenoxyethanol, Melia

Azadirachta Leaf Extract, Bisabolol, Glycerin,

t-Butyl Alcohol, Melia Azadirachta Flower

Extract, Ethylhexylglycerin, Centella Asiatica

Extract, Zingiber Officinale (Ginger) Root

Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose.......Acne Treatment

Section 55106-9 (55106-9)

Salicylic Acid 2%


Advanced Ingredient Data


Raw Label Data

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