drug facts

drug facts
SPL v13
SPL
SPL Set ID b34515cb-0495-4f70-be40-508df2990286
Route
topical
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (5 mg)
Inactive Ingredients
water glycerin myristic acid potassium hydroxide glyceryl stearate se stearic acid lauric acid palmitic acid coco glucoside edetate sodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-06-01

Purpose

Acne treatment

Description

Salicylic acid...0.5%


Medication Information

Warnings

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. 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.

Uses
  • clears acne blemishes and allows skin to heal
  • helps prevent new acne blemishes from forming
Purpose

Acne treatment

Directions
  • lather cream with water between palms
  • massage gently onto damp face, avoiding eyes
  • rinse off with clear water
  • dry without rubbing
Inactive Ingredients

water, glycerin, myristic acid, potassium hydroxide, glyceryl stearate SE, stearic acid, lauric acid, palmitic acid, coco-glucoside, tetrasodium EDTA

Description

Salicylic acid...0.5%

Section 51945-4

Active Ingredient

Salicylic acid...0.5%

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

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.

Uses
  • clears acne blemishes and allows skin to heal
  • helps prevent new acne blemishes from forming
Purpose

Acne treatment

Directions
  • lather cream with water between palms
  • massage gently onto damp face, avoiding eyes
  • rinse off with clear water
  • dry without rubbing
Inactive Ingredients (Inactive ingredients)

water, glycerin, myristic acid, potassium hydroxide, glyceryl stearate SE, stearic acid, lauric acid, palmitic acid, coco-glucoside, tetrasodium EDTA

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Salicylic acid...0.5%

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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