Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID b629cb05-548e-4d60-e053-2a95a90aeefb
Route
TOPICAL
Published
Effective Date 2020-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 mg)
Inactive Ingredients
Water Hydroxypropyl Cellulose, Unspecified Alcohol Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-10
Description

Active Ingredient: Salicylic Acid - 2%

Medication Information

Warnings and Precautions

Warnigs

  • For external use only
Indications and Usage

Uses:

  • For the treatment of acne.
Dosage and Administration

Directions

  • Apply a small portion over the affected area with finger tips and gently massage onto the skin.
  • Reapply as needed.
Description

Active Ingredient: Salicylic Acid - 2%

Section 50565-1

Keep out of reach of children:

  • If swallowed, get medical help or contact a Poison Control Centre right away.
Section 50566-9

Stop use and ask a doctor:

  • If severe skin irritation occurs.
  • Using other topical medication at the same time
Section 50567-7

When using this product

  • Avoid contact with eyes, lips and mouth.
  • Using other topical acne medication at the same time ot immefiately following use of this product may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor.
  • If sensitive to the sun or when increased sun exposure is expected use a sunscreen.
Section 51727-6

Other ingredients:

Water (aqua), SD Alcohol 40-B, Butylene Glycol, Hydroxypropylcellulose

Section 51945-4

Manufactured For Dermaquest ®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredient: Salicylic Acid - 2%

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • For the treatment of acne.
Dosage and Administration (34068-7)

Directions

  • Apply a small portion over the affected area with finger tips and gently massage onto the skin.
  • Reapply as needed.
Warnings and Precautions (34071-1)

Warnigs

  • For external use only
Section 50565-1 (50565-1)

Keep out of reach of children:

  • If swallowed, get medical help or contact a Poison Control Centre right away.
Section 50566-9 (50566-9)

Stop use and ask a doctor:

  • If severe skin irritation occurs.
  • Using other topical medication at the same time
Section 50567-7 (50567-7)

When using this product

  • Avoid contact with eyes, lips and mouth.
  • Using other topical acne medication at the same time ot immefiately following use of this product may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor.
  • If sensitive to the sun or when increased sun exposure is expected use a sunscreen.
Section 51727-6 (51727-6)

Other ingredients:

Water (aqua), SD Alcohol 40-B, Butylene Glycol, Hydroxypropylcellulose

Section 51945-4 (51945-4)

Manufactured For Dermaquest ®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1 (55105-1)

Purpose: Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient: Salicylic Acid - 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:39.375317 · Updated: 2026-03-14T23:05:33.999008