Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID bc0d1691-c13d-4c15-8c44-ecee30cb0ae2
Route
TOPICAL
Published
Effective Date 2023-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Hamamelis Virginiana Top Aloe Vera Leaf Sodium Borate Melaleuca Alternifolia Leaf East Indian Lemongrass Oil Glycerin Decyl Glucoside Cocamidopropyl Betaine Citric Acid Monohydrate Caprylyl Glycol Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-20

Description

Salicylic acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 2%

Uses

• for the treatment of acne

• clears acne blemishes and allows skin to heal

• helps prevent the development of new acne blemishes

Section 51945-4

Warnings

For external use only

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

Active Ingredient



Salicylic acid 2%

Other Information

store at 15°-30° C (59°-86° F) away from direct sunlight

Inactive Ingredients

water, hamamelis virginiana (witch hazel), bark/leaf/twig extract, aloe barbadensis leaf extract, sodium borate, melalecua alternifolia (tea tree) leaf oil, cymbopogon flexuosus oil, glycerin, decyl glucoside, cocamidopropyl betaine, citric acid, caprylyl glycol, phenoxyethanol, ethylhexylglycerin

When Using This Product

skin 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

Uses

• for the treatment of acne

• clears acne blemishes and allows skin to heal

• helps prevent the development of new acne blemishes

Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

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

Active Ingredient (Active ingredient)



Salicylic acid 2%

Other Information (Other information)

store at 15°-30° C (59°-86° F) away from direct sunlight

Inactive Ingredients (Inactive ingredients)

water, hamamelis virginiana (witch hazel), bark/leaf/twig extract, aloe barbadensis leaf extract, sodium borate, melalecua alternifolia (tea tree) leaf oil, cymbopogon flexuosus oil, glycerin, decyl glucoside, cocamidopropyl betaine, citric acid, caprylyl glycol, phenoxyethanol, ethylhexylglycerin

When Using This Product (When using this product)

skin 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

All Sections (JSON)