SPL v2
SPL
SPL Set ID 1f4108da-c83b-4b1d-e063-6294a90abfd7
Route
TOPICAL
Published
Effective Date 2022-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Pentylene Glycol Shea Butter Phenoxyethanol Caprylyl Glycol Edetate Disodium Disteareth-75 Isophorone Diisocyanate Water Medium-chain Triglycerides Centella Asiatica Leaf Tetrahexyldecyl Ascorbate Citric Acid Monohydrate Polysorbate 80 Butylene Glycol Betasizofiran Isohexadecane Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Propanediol Cetyl Palmitate Ethylhexyl Palmitate Glyceryl Monostearate Peg-100 Stearate Limosilactobacillus Fermentum Squalane Glycerin Sodium Hydroxide Xanthan Gum Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Morinda Citrifolia Whole Fu Ling Sucrose Hydroxyphenyl Propamidobenzoic Acid Sorbitan Monooleate Ascorbyl Palmitate Poly-l-lysine (30000-70000 Mw) Ethoxydiglycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-19
Description

Salicylic Acid 2%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

For the treatment of acne.

Dosage and Administration

Directions

■ 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.

■ Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Description

Salicylic Acid 2%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre immediately.

Section 50567-7

When using this product

■ skin irritation and dryness are 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.

■ Rinse right away with water if it gets in eyes.

Section 51727-6

Water/Aqua/Eau, Dimethicone, Ethylhexyl Palmitate, Propanediol, Glycerin, Ethoxydiglycol, Disteareth-75 IPDI, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Cetyl Palmitate, Lactobacillus Ferment, Butylene Glycol, Pentylene Glycol,

Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Phenoxyethanol, Xanthan Gum, Sclerotium Gum, Squalane, Sodium Hydroxide, Caprylyl Glycol, Centella Asiatica Leaf Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Morinda Citrifolia Extract, Isohexadecane, Tetrahexyldecyl Ascorbate, Poria Cocos Extract, Sucrose, Disodium EDTA, Hydroxyphenyl Propamidobenzoic Acid, Polysorbate 80, Citric Acid, Sorbitan Oleate, Ascorbyl Palmitate, Polylysine

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Acne Treatment

Section 55106-9

Salicylic Acid 2%

Structured Label Content

Indications and Usage (34067-9)

For the treatment of acne.

Dosage and Administration (34068-7)

Directions

■ 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.

■ Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Warnings and Precautions (34071-1)

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 immediately.

Section 50567-7 (50567-7)

When using this product

■ skin irritation and dryness are 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.

■ Rinse right away with water if it gets in eyes.

Section 51727-6 (51727-6)

Water/Aqua/Eau, Dimethicone, Ethylhexyl Palmitate, Propanediol, Glycerin, Ethoxydiglycol, Disteareth-75 IPDI, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Cetyl Palmitate, Lactobacillus Ferment, Butylene Glycol, Pentylene Glycol,

Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Phenoxyethanol, Xanthan Gum, Sclerotium Gum, Squalane, Sodium Hydroxide, Caprylyl Glycol, Centella Asiatica Leaf Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Morinda Citrifolia Extract, Isohexadecane, Tetrahexyldecyl Ascorbate, Poria Cocos Extract, Sucrose, Disodium EDTA, Hydroxyphenyl Propamidobenzoic Acid, Polysorbate 80, Citric Acid, Sorbitan Oleate, Ascorbyl Palmitate, Polylysine

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-823-7837

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

Salicylic Acid 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:57.578027 · Updated: 2026-03-14T23:13:28.374847