drug facts

drug facts
SPL v4
SPL
SPL Set ID b7d0d094-6a5b-4776-9f13-1f8d30542476
Route
topical
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (20 mg)
Inactive Ingredients
water glycerin isononyl isononanoate butylene glycol kaolin zinc sulfate sodium hydroxide hyaluronate sodium sodium benzoate phenoxyethanol ascorbyl glucoside trisodium ethylenediamine disuccinate biosaccharide gum-1 carbomer interpolymer type a (allyl sucrose crosslinked)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-09-01 Until 2023-06-01

Purpose

Acne treatment

Description

Salicylic acid...2%


Medication Information

Warnings

For external use only

Purpose

Acne treatment

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

Inactive Ingredients

water, glycerin, isononyl isononanoate, butylene glycol, kaolin, zinc sulfate, bifida ferment lysate, sodium hydroxide, sodium polyacrylate, sodium hyaluronate, sodium benzoate, phenoxyethanol, ascorbyl glucoside, hydrolyzed algin, trisodium ethylenediamine disuccinate, biosaccharide gum-1, acrylates/c10-30 alkyl acrylate crosspolymer, fragrance

Description

Salicylic acid...2%

Use

for the treatment of acne

Section 51945-4

Active Ingredient

Salicylic acid...2%

Questions Or Comments?

Call toll free 1-877-378-4245

Monday - Friday (9 a.m. to 5 p.m. EST)

When Using This Product

kin 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.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Purpose

Acne treatment

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, isononyl isononanoate, butylene glycol, kaolin, zinc sulfate, bifida ferment lysate, sodium hydroxide, sodium polyacrylate, sodium hyaluronate, sodium benzoate, phenoxyethanol, ascorbyl glucoside, hydrolyzed algin, trisodium ethylenediamine disuccinate, biosaccharide gum-1, acrylates/c10-30 alkyl acrylate crosspolymer, fragrance

Use

for the treatment of acne

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Salicylic acid...2%

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-378-4245

Monday - Friday (9 a.m. to 5 p.m. EST)

When Using This Product (When using this product)

kin 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.

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.


Advanced Ingredient Data


Raw Label Data

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