SPL v2
SPL
SPL Set ID 23a3d093-e89b-ddaf-e063-6394a90aaa6a
Route
TOPICAL
Published
Effective Date 2023-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Sodium Hydroxide Xanthan Gum Water Glycerin Glyceryl Monostearate Methyl Gluceth-20 Polyacrylamide (crosslinked; 2 Mole Percent Bisacrylamide) Laureth-7 Titanium Dioxide C13-14 Isoparaffin Epilobium Angustifolium Whole Edetate Disodium Limosilactobacillus Fermentum 1,2-hexanediol Allantoin Bentonite Sodium Metabisulfite Succinic Acid Phenoxyethanol Magnesium Aluminum Silicate Caprylyl Glycol Coco-caprylate Lactic Acid Tocopherol Polyoxyl 40 Hydrogenated Castor Oil Butylene Glycol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-09

Description

Salicylic Acid


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

For the treatment of acne

Dosage and Administration

■ Clean the skin thoroughly before applying this product.

■ Cover the entire affected area with a thin layer two to three times weekly. Leave on for 10-15 minutes. Rinse with warm water.

■ Because excessive drying of the skin may occur, start with one application weekly, then gradually increase to two or three times weekly if needed or as directed by a doctor.

■ If bothersome dryness or peeling occurs, reduce application frequency.

Description

Salicylic Acid

Section 50565-1

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

Section 50567-7

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.
Section 51727-6

Water/Aqua/Eau, Glycerin, PEG-40 Hydrogenated Castor Oil, Bentonite, Coco-Caprylate, Magnesium Aluminum Silicate, Titanium Dioxide, Butylene Glycol, Methyl Gluceth-20 Benzoate, Glyceryl Stearate, Lactobacillus Ferment, Sodium Metabisulfite, Tocopherol, Sodium Hydroxide, 1,2-Hexanediol, Caprylyl Glycol, Polyacrylamide, Epilobium Angustifolium Flower/Leaf/Stem Extract, C13-14

Isoparaffin, Succinic Acid, Xanthan Gum, Lactic Acid, Allantoin, Laureth-7, Disodium EDTA, Phenoxyethanol

Section 51945-4

Section 53413-1

1-888-823-7837

Section 55105-1

Acne Treatment

Section 55106-9

Salicylic Acid


Structured Label Content

Indications and Usage (34067-9)

For the treatment of acne

Dosage and Administration (34068-7)

■ Clean the skin thoroughly before applying this product.

■ Cover the entire affected area with a thin layer two to three times weekly. Leave on for 10-15 minutes. Rinse with warm water.

■ Because excessive drying of the skin may occur, start with one application weekly, then gradually increase to two or three times weekly if needed or as directed by a doctor.

■ If bothersome dryness or peeling occurs, reduce application frequency.

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 right away

Section 50567-7 (50567-7)

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.
Section 51727-6 (51727-6)

Water/Aqua/Eau, Glycerin, PEG-40 Hydrogenated Castor Oil, Bentonite, Coco-Caprylate, Magnesium Aluminum Silicate, Titanium Dioxide, Butylene Glycol, Methyl Gluceth-20 Benzoate, Glyceryl Stearate, Lactobacillus Ferment, Sodium Metabisulfite, Tocopherol, Sodium Hydroxide, 1,2-Hexanediol, Caprylyl Glycol, Polyacrylamide, Epilobium Angustifolium Flower/Leaf/Stem Extract, C13-14

Isoparaffin, Succinic Acid, Xanthan Gum, Lactic Acid, Allantoin, Laureth-7, Disodium EDTA, Phenoxyethanol

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)