SPL v1
SPL
SPL Set ID 38744214-18e8-e2fa-e063-6294a90a86fd
Route
TOPICAL
Published
Effective Date 2025-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.001 mg)
Inactive Ingredients
Glycerin Sodium Salicylate Phenoxyethanol Edetate Disodium Peg-40 Hydrogenated Castor Oil Fragrance Fresh Citrus Floral Orc1501495 Sorbitol Peg-10 Xanthan Gum Water Maltitol Melaleuca Alternifolia (tea Tree) Leaf Oil Mannitol Allantoin Diazolidinyl Urea Methylparaben Dimethicone Cyclodextrin Coceth-7 Sorbitan Trioleate Amino Acids Glycine Glyceryl Stearate Potassium Hydroxide Hydroxyethylcellulose Sorbitan Laurate Carbomer Cetearyl Alcohol Caprylic/capric Triglyceride Propylparaben Mineral Oil Peg-100 Stearate Sodium Laureth Sulfate Cocamidopropyl Betaine Sodium Chloride Decyl Glucoside Sodium Lauroyl Sarcosinate Styrene Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Polyquaternium-7 Ethylhexylglycerin Hamamelis Virginiana (witch Hazel) Leaf Water Oryza Sativa Whole Sodium Pca Pentylene Glycol Arginine Aspartic Acid Pca Alanine Serine Proline Sodium Hydroxide Sodium Lactate 1,2-hexanediol Chondrus Crispus Cocamide Mea Sodium Carbonate Hydroxyacetophenone Valine Yeast Histidine Phenylalanine Ethanolamine Threonine Marine Collagen, Soluble Glyceryl Caprylate Isoleucine Sodium Hyaluronate Caramel Triethanolamine

Identifiers & Packaging

Pill Appearance
Color: blue Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-26
Description

• clean the skin thoroughly before applying this product • 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 • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Medication Information

Warnings and Precautions

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 immediately.

Indications and Usage

• use every morning and evening

• apply a dime-size amount to damp skin and gently massage, avoiding the eye area

• rinse well

• if bothersome dryness or peeling occurs, reduce application use

• may be used on chest or back

Dosage and Administration

• clean the skin thoroughly before applying this product

• 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

• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Description

• clean the skin thoroughly before applying this product • 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 • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

WATER

SODIUM LAURETH SULFA

COCAMIDOPROPYL BETAINE

SODIUM CHLORID

DECYL GLUCOSIDE

COCAMIDE MEA

PHENOXYETHANOL

SODIUM LAUROYL SARCOSINATE

STYRENE/ACRYLATES COPOLYMER

DISODIUM EDTA

METHYLPARABEN

ACRYLATES/C10-30 ALKYL ACRYLATE

CROSSPOLYMER

POLYQUATERNIUM-7

GLYCERIN

FRAGRANCE

SODIUM HYDROXIDE

ETHYLHEXYLGLYCERIN

HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER

BIFIDA FERMENT FILTRATE

MELALEUCA ALTERNIFOLIA (TEA

TREE) LEAF OIL

ETHANOLAMINE

GLYCERYL CAPRYLAT

ORYZA SATIVA (RICE) LEES WATER

SODIUM CARBONATE

LACTOBACILLUS/RICE FERMENT

ALGAE OLIGOSACCHARIDES

SODIUM PCA

SODIUM LACTATE

1,2-HEXANEDIOL

PENTYLENE GLYCOL

ARGININ

YEAST EXTRACT

ASPARTIC ACID

HYDROXYACETOPHENONE

PCA

GLYCINE

ALANINE

CHONDRUS CRISPUS EXTRACT

SERINE

VALINE

PROLINE

THREONINE

ISOLEUCINE

SOLUBLE COLLAGEN

HISTIDINE

PHENYLALANINE

Section 51945-4

Section 55105-1

Treats acne - Helps prevent the development of new acne blemishes

Section 55106-9

SALICYLIC ACID--------0.24%

Structured Label Content

Indications and Usage (34067-9)

• use every morning and evening

• apply a dime-size amount to damp skin and gently massage, avoiding the eye area

• rinse well

• if bothersome dryness or peeling occurs, reduce application use

• may be used on chest or back

Dosage and Administration (34068-7)

• clean the skin thoroughly before applying this product

• 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

• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Warnings and Precautions (34071-1)

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 immediately.

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 51727-6 (51727-6)

WATER

SODIUM LAURETH SULFA

COCAMIDOPROPYL BETAINE

SODIUM CHLORID

DECYL GLUCOSIDE

COCAMIDE MEA

PHENOXYETHANOL

SODIUM LAUROYL SARCOSINATE

STYRENE/ACRYLATES COPOLYMER

DISODIUM EDTA

METHYLPARABEN

ACRYLATES/C10-30 ALKYL ACRYLATE

CROSSPOLYMER

POLYQUATERNIUM-7

GLYCERIN

FRAGRANCE

SODIUM HYDROXIDE

ETHYLHEXYLGLYCERIN

HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER

BIFIDA FERMENT FILTRATE

MELALEUCA ALTERNIFOLIA (TEA

TREE) LEAF OIL

ETHANOLAMINE

GLYCERYL CAPRYLAT

ORYZA SATIVA (RICE) LEES WATER

SODIUM CARBONATE

LACTOBACILLUS/RICE FERMENT

ALGAE OLIGOSACCHARIDES

SODIUM PCA

SODIUM LACTATE

1,2-HEXANEDIOL

PENTYLENE GLYCOL

ARGININ

YEAST EXTRACT

ASPARTIC ACID

HYDROXYACETOPHENONE

PCA

GLYCINE

ALANINE

CHONDRUS CRISPUS EXTRACT

SERINE

VALINE

PROLINE

THREONINE

ISOLEUCINE

SOLUBLE COLLAGEN

HISTIDINE

PHENYLALANINE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Treats acne - Helps prevent the development of new acne blemishes

Section 55106-9 (55106-9)

SALICYLIC ACID--------0.24%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:23.658547 · Updated: 2026-03-14T23:09:09.169888