Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 4952f699-f165-4222-9a3c-059a4a9be6c4
Route
TOPICAL
Published
Effective Date 2044-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1.15 mL)
Inactive Ingredients
Water Disodium Cocoamphodiacetate Cocamidopropyl Betaine Polyethylene Glycol 200 Sodium Chloride Zinc Pidolate Menthyl Lactate Chlorhexidine Gluconate Allantoin Lemon Oil Peppermint Oil Polysorbate 80 Phenoxyethanol Propylene Glycol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-07-15
Description

Purpose:   Acne Treatment

Medication Information

Warnings and Precautions

Warnings :

  • For external use only. 

  • Avoid contact with eyes and mucous membranes. 

  • Discontinue use if signs of irritation or rash appear.

Indications and Usage

 Uses:   For the daily cleansing of acne and oily-prone skin. 

Dosage and Administration

Directions :    Apply Cleansing Gel to previously moistened skin with a gentle massage until a soft lather is produced.  Leave for 1-2 minutes and then rinse.

Description

Purpose:   Acne Treatment

Section 50565-1

Keep out of reach of children.

Section 51727-6


COSMETIC INGREDIENTS:  WATER, DISODIUM COCOAMPHODIACETATE, PEG-7 CLYCERYL COCOATE, COCAMIDOPROPYL BETAINE, PEG-200 HYDROGENATED GLYCERYL PALMATE, SODIUM CHLORIDE, ZINC PCA, MENTHYL LACTATE, CHLORHEXIDINE DIGLUCONATE, ALLANTOIN, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, MENTHA PIPERITA (PEPPERMINT) OIL, POLYSORBATE 80, PHENOXYETHANOL, 2,4-DICHLOROBENZYL ALCOHOL, PROPYLENE GLYCOL, GLYCERIN.

Section 51945-4

Section 55105-1

Purpose:   Acne Treatment

Section 55106-9

Active Ingredient:

Salicylic Acid 1%

Structured Label Content

Indications and Usage (34067-9)

 Uses:   For the daily cleansing of acne and oily-prone skin. 

Dosage and Administration (34068-7)

Directions :    Apply Cleansing Gel to previously moistened skin with a gentle massage until a soft lather is produced.  Leave for 1-2 minutes and then rinse.

Warnings and Precautions (34071-1)

Warnings :

  • For external use only. 

  • Avoid contact with eyes and mucous membranes. 

  • Discontinue use if signs of irritation or rash appear.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)


COSMETIC INGREDIENTS:  WATER, DISODIUM COCOAMPHODIACETATE, PEG-7 CLYCERYL COCOATE, COCAMIDOPROPYL BETAINE, PEG-200 HYDROGENATED GLYCERYL PALMATE, SODIUM CHLORIDE, ZINC PCA, MENTHYL LACTATE, CHLORHEXIDINE DIGLUCONATE, ALLANTOIN, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, MENTHA PIPERITA (PEPPERMINT) OIL, POLYSORBATE 80, PHENOXYETHANOL, 2,4-DICHLOROBENZYL ALCOHOL, PROPYLENE GLYCOL, GLYCERIN.

Section 51945-4 (51945-4)

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:16.068314 · Updated: 2026-03-14T22:52:41.001711