Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 873de079-8b8d-45cd-8c7c-4645818f5aaa
Route
TOPICAL
Published
Effective Date 2024-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 mg)
Inactive Ingredients
Water Coco-betaine Propanediol Peg-120 Methyl Glucose Dioleate Sodium Chloride Sodium Cocoyl Glycinate Zinc Gluconate Glycerin Sodium Hydroxide Hydroxyacetophenone Caprylyl Glycol Citric Acid Monohydrate Trisodium Ethylenediamine Disuccinate Lactic Acid Acetic Acid Butylene Glycol Tocopherol Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Salicylic acid...0.05%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid...0.05%

Uses
  • for the treatment of acne
Section 51945-4

Warnings

For external use only

Directions

• use twice daily

• wet face, then work product into a lather

• massage onto face, avoiding eyes

• rinse well

Active Ingredient

Salicylic acid...0.05%

Inactive Ingredients

water, coco-betaine, propanediol, PEG-120 methyl glucose dioleate, sodium chloride, sodium cocoyl glycinate, zinc gluconate, glycerin, sodium hydroxide, bifida ferment lysate, hydroxyacetophenone, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, lactic acid, acetic acid, butylene glycol. Tocopherol, sodium benzoate, fragrance

Questions Or Comments?

Call toll free 1-877-378-4249

Monday - Friday (9 a.m. to 5 p.m. EST)

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.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • for the treatment of acne
Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions

• use twice daily

• wet face, then work product into a lather

• massage onto face, avoiding eyes

• rinse well

Active Ingredient (Active ingredient)

Salicylic acid...0.05%

Inactive Ingredients (Inactive ingredients)

water, coco-betaine, propanediol, PEG-120 methyl glucose dioleate, sodium chloride, sodium cocoyl glycinate, zinc gluconate, glycerin, sodium hydroxide, bifida ferment lysate, hydroxyacetophenone, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, lactic acid, acetic acid, butylene glycol. Tocopherol, sodium benzoate, fragrance

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-378-4249

Monday - Friday (9 a.m. to 5 p.m. EST)

When Using This Product (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.

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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