Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 935a58f0-d9a3-4423-9a5f-65fd19fad3db
Route
TOPICAL
Published
Effective Date 2023-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Glycerin Lauryl Glucoside Sodium Cocoyl Isethionate Decyl Glucoside Hamamelis Virginiana Top Aloe Vera Leaf Phenoxyethanol Ethylhexylglycerin Tea Tree Oil Hypromellose, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-01

Description

Salicylic acid 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic acid 2%

Uses

• for the treatment of acne

• clears acne blemishes and allows skin to heal

• helps prevent the development of new acne blemishes

Section 51945-4

Warnings

For external use only

Directions

  • wet the skin
  • dispense into wet hands and massage area gently
  • rinse thoroughly with warm water
  • cleanse twice daily
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Active Ingredient



Salicylic acid 2%

Other Information

store at 15°-30° C (59°-86° F) away from direct sunlight

Inactive Ingredients

water, natural beatine, glycerin, lauryl glucoside, sodium cocoyl isethionate, decyl glucoside, hamamelis virginiana (witch hazel) bark/leaf/twig extract, aloe barbadensis leaf extract, phenoxyethanol, ethylhexylglycerin, cymbopogon schoenanthus (lemongrass) leaf extract blend, melaleuca

alternafolia (tea tree) leaf oil, hydroxypropyl methylcellulose, guar cydroxypropyltrimonium chloride

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

• clears acne blemishes and allows skin to heal

• helps prevent the development of new acne blemishes

Section 51945-4 (51945-4)

Purpose

Acne treatment

Warnings

For external use only

Directions

  • wet the skin
  • dispense into wet hands and massage area gently
  • rinse thoroughly with warm water
  • cleanse twice daily
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Active Ingredient (Active ingredient)



Salicylic acid 2%

Other Information (Other information)

store at 15°-30° C (59°-86° F) away from direct sunlight

Inactive Ingredients (Inactive ingredients)

water, natural beatine, glycerin, lauryl glucoside, sodium cocoyl isethionate, decyl glucoside, hamamelis virginiana (witch hazel) bark/leaf/twig extract, aloe barbadensis leaf extract, phenoxyethanol, ethylhexylglycerin, cymbopogon schoenanthus (lemongrass) leaf extract blend, melaleuca

alternafolia (tea tree) leaf oil, hydroxypropyl methylcellulose, guar cydroxypropyltrimonium chloride

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

All Sections (JSON)