drug facts

drug facts
SPL v3
SPL
SPL Set ID fcc3c44b-3090-45b5-91e4-e591c92a08c8
Route
topical
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (5 mg)
Inactive Ingredients
water alcohol ascorbic acid propylene glycol dipropylene glycol laureth-23 milk thistle sodium citrate ferulic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-12-31 Until 2021-01-01

Purpose

Acne treatment

Description

Salicylic acid 0.5%


Medication Information

Warnings

For external use only

Uses

- for the treatment of acne

- reduces the number and severity of acne blemishes and allows skin to heal

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

Other Information

store in a cool, dark place

Inactive Ingredients

water, alcohol denat., ascorbic acid, propylene glycol, dipropylene glycol, laureth-23, silybum marianum fruit extract, sodium citrate, ferulic acid

Description

Salicylic acid 0.5%

Section 51945-4
Active Ingredient



Salicylic acid 0.5%

Flammable Until Dry.

Keep away from flames and heat.

Questions Or Comments?

Call 1-800-811-1660 Monday - Friday (9 a.m. - 5 p.m. CST)

When Using This Product

skin irritation and dryness is more liekly 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

Uses

- for the treatment of acne

- reduces the number and severity of acne blemishes and allows skin to heal

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

Other Information (Other information)

store in a cool, dark place

Inactive Ingredients (Inactive ingredients)

water, alcohol denat., ascorbic acid, propylene glycol, dipropylene glycol, laureth-23, silybum marianum fruit extract, sodium citrate, ferulic acid

Section 51945-4 (51945-4)
Active Ingredient (Active ingredient)



Salicylic acid 0.5%

Flammable Until Dry. (Flammable until dry.)

Keep away from flames and heat.

Questions Or Comments? (Questions or comments?)

Call 1-800-811-1660 Monday - Friday (9 a.m. - 5 p.m. CST)

When Using This Product (When using this product)

skin irritation and dryness is more liekly 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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