Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 9429f477-a916-49c9-bf04-1cf591af5c7f
Route
TOPICAL
Published
Effective Date 2014-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Syringa Vulgaris Whole Masoprocol Oleanolic Acid Citric Acid Monohydrate Salix Alba Bark Phenoxyethanol Sodium Polystyrene Sulfonate Medium-chain Triglycerides Carrageenan Water Kaolin Glycerin Magnesium Aluminum Silicate Xanthan Gum Allantoin Orange Butylene Glycol Hyaluronate Sodium Crithmum Maritimum Peg-60 Almond Glycerides Carbomer Homopolymer, Unspecified Type Caprylyl Glycol Hexylene Glycol Maltodextrin Aloe Vera Leaf Niacinamide Ethyl Linoleate Hexylresorcinol Ethylhexylglycerin Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-05-04
Description

Active Ingredient: Salicylic Acid- 2%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Indications and Usage

Uses:

For the treatment of acne.

Dosage and Administration

Directions:

  • Apply thin layer in affected areas after cleansing using finger tips.
  • Massage gently in circular movements for 1-2 minutes and allow the product to remain on skin for 5-10 minutes, depending on the skin tolerance and/or sensitivity.
  • Rinse well and follow suggested post-mask home care regimen.
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 center 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 the eyes, lips and mouth.
  • Using other topical acne medications at the same time or immediately 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 50569-3

Stop use and ask a Doctor

  • If severe skin irritation occurs.
  • Using other topical medication at the same time.
Section 50570-1

Do not use if you have very sensitive skin.

Section 51727-6

Inavtive Ingredients:

Water (Aqua), Kaolin, Magnesium Aluminum Silicate, Glycerin, Butylene Glycol, Sodium Hyaluronate, Sodium Polystyrene Sulfonate, Xanthan Gum, Allantoin, Salix Alba (Willow) Bark Extract, Citrus Aurantium Dulcis (Orange) Callus Culture Extract , Crithmum Maritimum Callus Culture Filtrate, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, PEG-60 Almond Glycerides, Carbomer, Nordihydroguaiaretic Acid, Oleanolic Acid, Niacinamide, Caprylic/Capric Triglyceride, Ethyl Linoleate, Hexylresorcinol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Maltodextrin, Carrageenan , Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Citric Acid,

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 thin layer in affected areas after cleansing using finger tips.
  • Massage gently in circular movements for 1-2 minutes and allow the product to remain on skin for 5-10 minutes, depending on the skin tolerance and/or sensitivity.
  • Rinse well and follow suggested post-mask home care regimen.
Warnings and Precautions (34071-1)

Warnings:

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 center 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 the eyes, lips and mouth.
  • Using other topical acne medications at the same time or immediately 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 50569-3 (50569-3)

Stop use and ask a Doctor

  • If severe skin irritation occurs.
  • Using other topical medication at the same time.
Section 50570-1 (50570-1)

Do not use if you have very sensitive skin.

Section 51727-6 (51727-6)

Inavtive Ingredients:

Water (Aqua), Kaolin, Magnesium Aluminum Silicate, Glycerin, Butylene Glycol, Sodium Hyaluronate, Sodium Polystyrene Sulfonate, Xanthan Gum, Allantoin, Salix Alba (Willow) Bark Extract, Citrus Aurantium Dulcis (Orange) Callus Culture Extract , Crithmum Maritimum Callus Culture Filtrate, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, PEG-60 Almond Glycerides, Carbomer, Nordihydroguaiaretic Acid, Oleanolic Acid, Niacinamide, Caprylic/Capric Triglyceride, Ethyl Linoleate, Hexylresorcinol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Maltodextrin, Carrageenan , Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Citric Acid,

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: 2026-02-15T12:04:37.590461 · Updated: 2026-03-14T23:05:29.389553