Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 60a1e840-58f6-48cb-a997-e133bdc60623
Route
TOPICAL
Published
Effective Date 2015-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Glycerin Cocamidopropyl Betaine Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Sodium Chloride Hydrogenated Castor Oil Carrageenan C12-15 Alkyl Lactate Edetate Disodium Cocamidopropyl Pg-dimonium Chloride Phosphate Pummelo Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Green Tea Leaf Ascorbyl Palmitate Neopentyl Glycol Dicaprylate/dicaprate Chamaemelum Nobile Flower Polysorbate 20 Polyvinyl Alcohol Propylene Glycol Butylene Glycol Sodium Benzotriazolyl Butylphenol Sulfonate Agar Mica Titanium Dioxide Sodium Hydroxide D&c Red No. 30 Fd&c Red No. 40 Ext. D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-12-08

Description

Salicylic Acid 2%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 2%

Uses

for the treatment of acne.

Warnings

For external use only

Directions
  • use twice a day
  • wet face
  • apply to hands with some water and work into lather
  • gently massage face and rinse thoroughly
Label Copy

Active Ingredient

Salicylic Acid 2%

Other Information

store between 20°C - 25°C (68 - 77°F)

Questions/comments?

1-800-925-4733

Inactive Ingredients

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Glycerin, Cocamidopropyl Betaine, Acrylates Copolymer, Sodium Chloride, Hydrogenated Castor Oil, Carrageenan, C12-15 Alkyl Lactate, Disodium EDTA, Cocamidopropyl PG-Dimonium Chloride Phosphate, Citrus Grandis (Grapefruit) Fruit Extract, Polyquaternium-7, Camellia Sinesis Leaf Extract, Ascorbyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Anthemis Nobilis Flower Extract, Polysorbate 20, Polyvinyl Alcohol, Propylene Glycol, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Agar, Mica, Titanium Dioxide (CI 77891), Sodium Hydroxide, Red 30 (CI 73360), Red 40 (CI 16035), Ext. Violet 2 (CI 60730), Fragrance (Parfum).

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop Using This Product and Ask A Doctor If

irritation or redness develops and lasts

Ask A Doctor Or Pharmacist Before Use If You Are

using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise directed by a doctor.


Structured Label Content

Uses

for the treatment of acne.

Purpose

Acne Treatment

Warnings

For external use only

Directions
  • use twice a day
  • wet face
  • apply to hands with some water and work into lather
  • gently massage face and rinse thoroughly
Label Copy

Active Ingredient (Active ingredient)

Salicylic Acid 2%

Other Information (Other information)

store between 20°C - 25°C (68 - 77°F)

Questions/comments?

1-800-925-4733

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Glycerin, Cocamidopropyl Betaine, Acrylates Copolymer, Sodium Chloride, Hydrogenated Castor Oil, Carrageenan, C12-15 Alkyl Lactate, Disodium EDTA, Cocamidopropyl PG-Dimonium Chloride Phosphate, Citrus Grandis (Grapefruit) Fruit Extract, Polyquaternium-7, Camellia Sinesis Leaf Extract, Ascorbyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Anthemis Nobilis Flower Extract, Polysorbate 20, Polyvinyl Alcohol, Propylene Glycol, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Agar, Mica, Titanium Dioxide (CI 77891), Sodium Hydroxide, Red 30 (CI 73360), Red 40 (CI 16035), Ext. Violet 2 (CI 60730), Fragrance (Parfum).

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)

irritation or redness develops and lasts

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise directed by a doctor.


Advanced Ingredient Data


Raw Label Data

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