Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 5b1c8f11-3b5b-4c26-b4c1-0770d1dd823a
Route
TOPICAL
Published
Effective Date 2018-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Alcohol Allantoin Capryloyl Glycine Isoceteth-20 Ethyl Jojobate Peg-8/smdi Copolymer Fytic Acid Water Edetate Trisodium Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-01

Description

Salicylic acid 2%

Purpose

Salicylic acid - Acne treatment


Medication Information

Purpose

Salicylic acid - Acne treatment

Description

Salicylic acid 2%

Uses

treats and helps prevent acne

Warnings

For external use only

Directions
  • use a pad to cleanse and cover the affected area with a thin layer of medicine 1 to 3 times daily
  • because too much drying of the skin may occur, start with 1 application, then gradually increase to 2 or 3 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: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.

Other information

  • KEEP TIGHTLY CLOSED
  • avoid storing at temperatures above 100˚F (38˚C)
  • protect from freezing
  • keep away from flame, fire and heat
Questions?

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

Active Ingredient

Salicylic acid 2%

Inactive Ingredients

alcohol (50% v/v), allantoin, capryloyl glycine, fragrance, isoceteth-20, jojoba wax PEG-120 esters, PEG-8/SMDI copolymer, phytic acid, purified water, trisodium EDTA, trolamine

Principal Display Panel
When Using This Product
  • keep away from eyes, lips and mouth. 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.
  • do not leave pad on skin
If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children.

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

Package/label Principal Display Panel

Structured Label Content

Uses

treats and helps prevent acne

Purpose

Salicylic acid - Acne treatment

Warnings

For external use only

Directions
  • use a pad to cleanse and cover the affected area with a thin layer of medicine 1 to 3 times daily
  • because too much drying of the skin may occur, start with 1 application, then gradually increase to 2 or 3 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: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.

Other information

  • KEEP TIGHTLY CLOSED
  • avoid storing at temperatures above 100˚F (38˚C)
  • protect from freezing
  • keep away from flame, fire and heat
Questions?

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

Active Ingredient (Active ingredient)

Salicylic acid 2%

Inactive Ingredients (Inactive ingredients)

alcohol (50% v/v), allantoin, capryloyl glycine, fragrance, isoceteth-20, jojoba wax PEG-120 esters, PEG-8/SMDI copolymer, phytic acid, purified water, trisodium EDTA, trolamine

Principal Display Panel
When Using This Product (When using this product)
  • keep away from eyes, lips and mouth. 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.
  • do not leave pad on skin
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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