SPL v1
SPL
SPL Set ID 3d0511f6-168b-5377-e063-6294a90a3ca9
Route
TOPICAL
Published
Effective Date 2025-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.0108 g)
Inactive Ingredients
Glyceryl Stearate Peg-40 Hydrogenated Castor Oil C12-20 Alkyl Glucoside Centella Asiatica Root 1,2-hexanediol Cetyl Ethylhexanoate Water Dipropylene Glycol Peg-100 Stearate Cetearyl Alcohol Niacinamide Menthol Dipotassium Glycyrrhizate Xanthan Gum C14-22 Alcohols Citric Acid Ci 77492 Caprylic/capric Triglyceride Dimethicone Betaine Hydroxyacetophenone Sodium Hydroxide Butylene Glycol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s)

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-30

Description

SALICYLIC ACID1.08%


Medication Information

Warnings and Precautions

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. lf irritation occurs, only use one topical acne medication at a time.

Indications and Usage

For the treatment of acne

Reduces the number of acne blemishes

Helps prevent the development of new acne pimples

Dosage and Administration

Directions

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

SALICYLIC ACID1.08%

Section 50565-1

lf Swallowed, Get Medica Help or Contact a Poison Control Center right away

Section 51727-6

Water, Butylene Glycol, Caprylic/Capric Triglyceride,Cetyl Ethylhexanoate, Propylene Glycol, Dimethicone Cetearyl Alcohol, C14-22 Alcohols, Glyceryl Stearate,Niacinamide, Betaine,PEG-100 Stearate, 1,2-Hexanediol,Hydroxyacetophenone, Sodium Hydroxide, PEG-40 Hydrogenated Castor Oil, C12-20 Alkyl Glucoside,Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum,Centella Asiatica Root Extract, Menthol, Dipotassium Glycyrrhizate, Citric Acid, lron Oxides (Cl 77492)

Section 51945-4

Section 55105-1

Acne treatment

Section 55106-9

SALICYLIC ACID1.08%

Section 60561-8

protect the product in this container from excessive

heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

For the treatment of acne

Reduces the number of acne blemishes

Helps prevent the development of new acne pimples

Dosage and Administration (34068-7)

Directions

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)

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. lf irritation occurs, only use one topical acne medication at a time.

Section 50565-1 (50565-1)

lf Swallowed, Get Medica Help or Contact a Poison Control Center right away

Section 51727-6 (51727-6)

Water, Butylene Glycol, Caprylic/Capric Triglyceride,Cetyl Ethylhexanoate, Propylene Glycol, Dimethicone Cetearyl Alcohol, C14-22 Alcohols, Glyceryl Stearate,Niacinamide, Betaine,PEG-100 Stearate, 1,2-Hexanediol,Hydroxyacetophenone, Sodium Hydroxide, PEG-40 Hydrogenated Castor Oil, C12-20 Alkyl Glucoside,Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum,Centella Asiatica Root Extract, Menthol, Dipotassium Glycyrrhizate, Citric Acid, lron Oxides (Cl 77492)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne treatment

Section 55106-9 (55106-9)

SALICYLIC ACID1.08%

Section 60561-8 (60561-8)

protect the product in this container from excessive

heat and direct sun


Advanced Ingredient Data


Raw Label Data

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