Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 07f51d83-e956-442c-9afa-aa987a66ae9e
Route
TOPICAL
Published
Effective Date 2017-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Sodium Coco-sulfate Cocamidopropyl Betaine Sodium Cocoyl Isethionate Synthetic Wax (1200 Mw) Magnesium Silicate Sodium Polyacrylate (8000 Mw) Methyl Perfluoroisobutyl Ether Methyl Perfluorobutyl Ether Polyisobutylene (1000 Mw) Polysorbate 20 Polyhydroxystearic Acid (2300 Mw) Isononyl Isononanoate Ethylhexyl Isononanoate Xanthan Gum Disodium Edta-copper Phenoxyethanol Sodium Bisulfite Sodium Hydride Butylene Glycol Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-30

Description

Salicylic Acid 2%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 2%

Uses
  • Treats Acne
  • Helps prevent the development of new acne blemishes
Warnings

Using other topical acne medications at the same tiem or immediatly following use of this prouct may increase dryness or irritation of the skin. If this occurs, only one medication shoul be used unless directed by a doctor.

For external use only

When using this product

• avoid contact with the eyes

• if contact occurs, rinse thoroughly with water

• do not use on damaged or broken skin

Directions
  • Use once or twice daily to cleanse skin thoroughly
  • Dispense a small amount onto dampened face
  • Massage gently for up to 60 seconds
  • Rinse thoroughly with water, towel dry
  • If bothersome dryness or peeling occurs, reduce use to once a day or every other ay
Active Ingredients

Salicylic Acid 2%

Inactive Ingredients

Aqua/Water/Eau, Sodium Cocoyl Apple Amino Acids, Cocamidopropyl Betaine, Sodium Cocoyl Isethionate, Synthetic Wax, Magnesium Silicate, Polyacrylate-13, Methyl Perfluoroisobutyl Ether, Methyl Perfluorobutyl Ether, Polyisobutene, Polysorbate 20, Polyhydroxystearic Acid, Isononyl Isononanoate, Ethylhexyl Isononanoate, Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Sodium Bisulfite, Sodium Hydroxide, Parfum/Fragrance, Butylene Glycol, Iodopropynyl Butylcarbamate, Limonene

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.


Structured Label Content

Uses
  • Treats Acne
  • Helps prevent the development of new acne blemishes
Purpose

Acne Treatment

Warnings

Using other topical acne medications at the same tiem or immediatly following use of this prouct may increase dryness or irritation of the skin. If this occurs, only one medication shoul be used unless directed by a doctor.

For external use only

When using this product

• avoid contact with the eyes

• if contact occurs, rinse thoroughly with water

• do not use on damaged or broken skin

Directions
  • Use once or twice daily to cleanse skin thoroughly
  • Dispense a small amount onto dampened face
  • Massage gently for up to 60 seconds
  • Rinse thoroughly with water, towel dry
  • If bothersome dryness or peeling occurs, reduce use to once a day or every other ay
Active Ingredients

Salicylic Acid 2%

Inactive Ingredients

Aqua/Water/Eau, Sodium Cocoyl Apple Amino Acids, Cocamidopropyl Betaine, Sodium Cocoyl Isethionate, Synthetic Wax, Magnesium Silicate, Polyacrylate-13, Methyl Perfluoroisobutyl Ether, Methyl Perfluorobutyl Ether, Polyisobutene, Polysorbate 20, Polyhydroxystearic Acid, Isononyl Isononanoate, Ethylhexyl Isononanoate, Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Sodium Bisulfite, Sodium Hydroxide, Parfum/Fragrance, Butylene Glycol, Iodopropynyl Butylcarbamate, Limonene

Principal Display Panel

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

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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