Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID de384124-cdb9-4d6b-ae4d-351214182c58
Route
TOPICAL
Published
Effective Date 2011-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 uL)
Inactive Ingredients
Water Alcohol Hamamelis Virginiana Bark Sodium Lactate Ppg-5-ceteth-20 Peg-12 Dimethicone Linalool, (+/-)- Butylene Glycol Carbocysteine Lysine Propylene Glycol Menthol Sanguisorba Minor Root Chinese Cinnamon Ginger Dulse Crithmum Maritimum Himanthalia Elongata Mastocarpus Stellatus Macrocystis Pyrifera Sea Salt

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-09-01
Description

Active ingredient Salicylic Acid 1%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable - Keep away from open fire or flame.

Indications and Usage

Use for the treatment of acne.

Dosage and Administration

Directions After cleansing, sweep pad

gently over face and neck.

Description

Active ingredient Salicylic Acid 1%

Section 50565-1

Keep out of reach of children. If swallowed,

get medical help or contact a Poison Control

Center right away.



Section 50568-5

Ask a doctor or pharmacist before use if you

are using other topical acne medications at the

same time or immediately following use of this

product. This may increase dryness or irritation

of the skin. If this occurs, only one medication

should be used unless directed by a doctor.

Section 51727-6

Inactive ingredients

Water, SD Alcohol 39-C, Hamamelis Virginiana (Witch

Hazel) Bark/Leaf/Twig Extract, Sodium Lactate,

PPG-5-Ceteth-20, PEG-12 Dimethicone, Fragrance

(Parfum), Linalool, Allantoin, Butylene Glycol, Lysine

Carboxymethyl Cysteinate, Propylene Glycol, Menthol,

Poterium Officinale Extract, Cinnamomum Cassia

Bark Extract, Zingiber Officinale (Ginger) Root Extract,

Palmaria Palmata Extract, Crithmum Maritimum

Extract, Himanthalia Elongata Extract, Gigartina

Stellata Extract, Macrocystis Pyrifera Extract, Sea

Salt (Maris Sal), Blue 1 (CI 42090), Yellow 5 (CI 19140)

Section 51945-4
Image of label aaep242.jpg
Section 55105-1

Purpose

Acne Treatment

Section 55106-9

Active ingredient

Salicylic Acid 1%

Structured Label Content

Indications and Usage (34067-9)

Use for the treatment of acne.

Dosage and Administration (34068-7)

Directions After cleansing, sweep pad

gently over face and neck.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable - Keep away from open fire or 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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you

are using other topical acne medications at the

same time or immediately following use of this

product. This may increase dryness or irritation

of the skin. If this occurs, only one medication

should be used unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive ingredients

Water, SD Alcohol 39-C, Hamamelis Virginiana (Witch

Hazel) Bark/Leaf/Twig Extract, Sodium Lactate,

PPG-5-Ceteth-20, PEG-12 Dimethicone, Fragrance

(Parfum), Linalool, Allantoin, Butylene Glycol, Lysine

Carboxymethyl Cysteinate, Propylene Glycol, Menthol,

Poterium Officinale Extract, Cinnamomum Cassia

Bark Extract, Zingiber Officinale (Ginger) Root Extract,

Palmaria Palmata Extract, Crithmum Maritimum

Extract, Himanthalia Elongata Extract, Gigartina

Stellata Extract, Macrocystis Pyrifera Extract, Sea

Salt (Maris Sal), Blue 1 (CI 42090), Yellow 5 (CI 19140)

Section 51945-4 (51945-4)
Image of label aaep242.jpg
Section 55105-1 (55105-1)

Purpose

Acne Treatment

Section 55106-9 (55106-9)

Active ingredient

Salicylic Acid 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.678402 · Updated: 2026-03-14T22:52:54.626056