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

Description

Salicylic acid...0.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid...0.5%

Uses
  • clears acne blemishes and allows skin to heal
  • helps prevent new acne blemishes from forming
Section 51945-4

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.

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

Salicylic acid...0.5%

Inactive Ingredients

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

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • clears acne blemishes and allows skin to heal
  • helps prevent new acne blemishes from forming
Section 51945-4 (51945-4)

Purpose

Acne treatment

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.

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

Salicylic acid...0.5%

Inactive Ingredients (Inactive ingredients)

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

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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