b0ad3d4c-7afa-4503-b5d6-c88bf898155e

SPL v5
SPL
SPL Set ID b0ad3d4c-7afa-4503-b5d6-c88bf898155e
Route
topical
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (5 mg)
Inactive Ingredients
water sodium pyrrolidone carboxylate ammonium lauryl sulfate succinic acid phosphoric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-05-31
Purpose

Acne Treatment

Description

Salicylic Acid 0.5%

Medication Information

Warnings

For external use only.

When using this product:Avoid contact with eyes and mouth. If contact occurs, rinse thoroughly with water. 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 acne medication at a time. Limit use to face and neck.

Uses

For the treatment of acne.

Purpose

Acne Treatment

Directions
  • 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, Sodium PCA, Ammonium Lauryl Sulfate, Succinic Acid, Phosphoric Acid.

Description

Salicylic Acid 0.5%

Section 44425-7
  • Store in a cool, dry place
  • Do not freeze

Questions or comments?[email protected]

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Productlabel

Active Ingredient

Salicylic Acid 0.5%

Structured Label Content

Warnings

For external use only.

When using this product:Avoid contact with eyes and mouth. If contact occurs, rinse thoroughly with water. 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 acne medication at a time. Limit use to face and neck.

Uses

For the treatment of acne.

Purpose

Acne Treatment

Directions
  • 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, Sodium PCA, Ammonium Lauryl Sulfate, Succinic Acid, Phosphoric Acid.

Section 44425-7 (44425-7)
  • Store in a cool, dry place
  • Do not freeze

Questions or comments?[email protected]

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Productlabel (ProductLabel)

Active Ingredient

Salicylic Acid 0.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:06.797031 · Updated: 2026-03-14T23:06:25.914429