drug facts

drug facts
SPL v2
SPL
SPL Set ID d8ad899b-a4d9-4720-aa37-b35d95ff899c
Route
topical
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (15 mg)
Inactive Ingredients
water coco glucoside propylene glycol ammonium polyacryloyldimethyl taurate (55000 mpa.s) glycerin coco-betaine sodium cocoyl isethionate sodium methyl cocoyl taurate dipropylene glycol sodium chloride butylene glycol phenoxyethanol hydrogenated coconut oil capryloyl salicylic acid coconut acid tert-butyl alcohol sodium pyrrolidone carboxylate camphor (synthetic) menthol indian frankincense sodium isethionate hamamelis virginiana top water peumus boldus leaf edetate disodium alcohol ginger sanguisorba officinalis root chinese cinnamon xanthan gum saccharina latissima zinc sulfate pyridoxine hydrochloride sodium hydroxide citric acid monohydrate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-04-26

Purpose

Acne treatment

Description

Salicylic acid 1.5%


Medication Information

Warnings

For external use only

Purpose

Acne treatment

Directions
  • wet face, then work product into a lather
  • massage onto face avoiding the eye area
  • rinse well
  • use twice daily
Inactive Ingredients

water, coco-glucoside, propylene glycol, ammonium polyacryloyldimethyl taurate, glycerin, coco-betaine, sodium cocoyl isethionate, sodium methyl cocoyl taurate, dipropylene glycol, sodium chloride, butylene glycol, phenoxyethanol, hydrogenated coconut acid, capryloyl salicylic acid, coconut acid, t-butyl alcohol, sodium pca, camphor, menthol, boswellia serrata extract, sodium isethionate, hamamelis virginiana (witch hazel) water, peumus boldus leaf extract, disodium EDTA, alcohol, zingiber officinale (ginger) root extract, sanguisorba officinalis root extract, cinnamomum cassia bark extract, xanthan gum, laminaria saccharina extract, zinc sulfate, pyridoxine HCL, sodium hydroxide, citric acid

Description

Salicylic acid 1.5%

Use

for the treatment of acne

Section 51945-4

Active Ingredient



Salicylic acid 1.5%

Questions Or Comments?

Call toll free 1-800-946-4453

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

Warnings

For external use only

Purpose

Acne treatment

Directions
  • wet face, then work product into a lather
  • massage onto face avoiding the eye area
  • rinse well
  • use twice daily
Inactive Ingredients (Inactive ingredients)

water, coco-glucoside, propylene glycol, ammonium polyacryloyldimethyl taurate, glycerin, coco-betaine, sodium cocoyl isethionate, sodium methyl cocoyl taurate, dipropylene glycol, sodium chloride, butylene glycol, phenoxyethanol, hydrogenated coconut acid, capryloyl salicylic acid, coconut acid, t-butyl alcohol, sodium pca, camphor, menthol, boswellia serrata extract, sodium isethionate, hamamelis virginiana (witch hazel) water, peumus boldus leaf extract, disodium EDTA, alcohol, zingiber officinale (ginger) root extract, sanguisorba officinalis root extract, cinnamomum cassia bark extract, xanthan gum, laminaria saccharina extract, zinc sulfate, pyridoxine HCL, sodium hydroxide, citric acid

Use

for the treatment of acne

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)



Salicylic acid 1.5%

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

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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