SPL v3
SPL
SPL Set ID 7db929b6-6470-4840-b016-7e19688548dd
Route
TOPICAL
Published
Effective Date 2024-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Citric Acid Monohydrate Edetate Disodium Anhydrous Menthol Polyethylene Glycol 400 Propylene Glycol Water Alcohol Sodium Lauryl Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

Salicylic Acid 2%...................Acne Treatment

Purpose

Salicylic Acid 2%...................Acne Treatment


Medication Information

Purpose

Salicylic Acid 2%...................Acne Treatment

Description

Salicylic Acid 2%...................Acne Treatment

Uses

for the treatment of acne • reduces the number of acne pimples and blackheads • allows skin to heal • helps prevent new acne pimples from forming

Section 51945-4

Section 55105-1

Warnings

For external use only

Directions

cleanse the skin thoroughly before using the product • use the pad to clean and treat the entire affected area one to three times daily. Do not rinse. • 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 doctor • if bothersome dryness or peeling occurs, reduce the application to once a day or every other day

Do Not Use

if you have very sensitive skin or known allergy to salicylic acid

Stop use and ask a doctor ifexcessive itching, dryness, redness, burning or swelling occurs or if these symptoms persist

Inactive Ingredients

citric acid, disodium EDTA, fragrance, menthol, PEG-8, propylene glycol, purified water, SD alcohol 40-B, sodium lauryl sulfate

When Using This Product

keep away from eyes,lips, other mucous membranes. If contact occurs flush thoroughly with water • do not leave pad on skin for an extended period of time

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient                  Purpose

Salicylic Acid 2%...................Acne Treatment


Structured Label Content

Uses

for the treatment of acne • reduces the number of acne pimples and blackheads • allows skin to heal • helps prevent new acne pimples from forming

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Warnings

For external use only

Directions

cleanse the skin thoroughly before using the product • use the pad to clean and treat the entire affected area one to three times daily. Do not rinse. • 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 doctor • if bothersome dryness or peeling occurs, reduce the application to once a day or every other day

Do Not Use (Do not use)

if you have very sensitive skin or known allergy to salicylic acid

Stop use and ask a doctor ifexcessive itching, dryness, redness, burning or swelling occurs or if these symptoms persist

Inactive Ingredients (Inactive ingredients)

citric acid, disodium EDTA, fragrance, menthol, PEG-8, propylene glycol, purified water, SD alcohol 40-B, sodium lauryl sulfate

When Using This Product (When using this product)

keep away from eyes,lips, other mucous membranes. If contact occurs flush thoroughly with water • do not leave pad on skin for an extended period of time

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient                  Purpose

Salicylic Acid 2%...................Acne Treatment


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)