Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 21b64a3f-2c90-1c1a-e063-6294a90a0ea0
Route
TOPICAL
Published
Effective Date 2024-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (18 mg)
Inactive Ingredients
Alpha-tocopherol Acetate Cocamidopropyl Betaine Hyaluronic Acid Edetate Disodium Hydroxyphenyl Propamidobenzoic Acid Pentylene Glycol Glycerin Sodium Benzoate Sodium Hydroxide Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) Caprylyl/capryl Oligoglucoside Chamomile Sodium C14-16 Olefin Sulfonate Disodium Cocoamphodiacetate Sodium Chloride Water Sodium Methyl Cocoyl Taurate Potassium Sorbate Aloe Vera Leaf Butylene Glycol Anhydrous Citric Acid Fragrance 13576

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-15

Description

Salicylic acid 2%

Purpose

Acne treatment


Medication Information

Warnings and Precautions

For external use only

Purpose

Acne treatment

Description

Salicylic acid 2%

Uses
  • for the treatment of acne
  • clears acne pimples and allows skin to heal
  • helps prevent new acne pimples from forming
Section 51945-4

Questions

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Directions
  • use daily in the shower or bath
  • massage over wet skin with a washcloth or body puff, concentrating on areas prone to breakouts
  • rinse thoroughly
  • follow with a non-comedogenic moisturizer if needed
Active Ingredient

Salicylic acid 2%

Inactive Ingredients

water, sodium C14-16 olefin sulfonate, disodium cocoamphodiacetate, cocamidopropyl betaine, sodium methyl cocoyl taurate, glycerin, acrylates copolymer, aloe barbadensis leaf juice, butylene glycol, caprylyl/capryl glucoside, chamomilla recutita (matricaria) flower extract, citric acid, disodium EDTA, fragrance, hydroxyphenyl propamidobenzoic acid, hydroxypropyltrimonium hyaluronate, pentylene glycol, potassium sorbate, sodium benzoate, sodium chloride, sodium hydroxide, tocopheryl acetate [vitamin E]

Principal Display Panel

When Using This Product
  • avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • 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 right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.


Structured Label Content

Uses
  • for the treatment of acne
  • clears acne pimples and allows skin to heal
  • helps prevent new acne pimples from forming
Warnings and Precautions (34071-1)

For external use only

Section 51945-4 (51945-4)

Purpose

Acne treatment

Questions

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Directions
  • use daily in the shower or bath
  • massage over wet skin with a washcloth or body puff, concentrating on areas prone to breakouts
  • rinse thoroughly
  • follow with a non-comedogenic moisturizer if needed
Active Ingredient (Active ingredient)

Salicylic acid 2%

Inactive Ingredients (Inactive ingredients)

water, sodium C14-16 olefin sulfonate, disodium cocoamphodiacetate, cocamidopropyl betaine, sodium methyl cocoyl taurate, glycerin, acrylates copolymer, aloe barbadensis leaf juice, butylene glycol, caprylyl/capryl glucoside, chamomilla recutita (matricaria) flower extract, citric acid, disodium EDTA, fragrance, hydroxyphenyl propamidobenzoic acid, hydroxypropyltrimonium hyaluronate, pentylene glycol, potassium sorbate, sodium benzoate, sodium chloride, sodium hydroxide, tocopheryl acetate [vitamin E]

Principal Display Panel

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • 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 (Keep out of reach of children)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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