SPL v1
SPL
SPL Set ID 39ea674d-ff6e-a8c6-e063-6394a90a0656
Route
TOPICAL
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 mg)
Inactive Ingredients
Glyceryl Stearate Se Polyglyceryl-6 Caprylate Phenoxyethanol Polyacrylamide (10000 Mw) Cetyl Alcohol C13-14 Isoparaffin Pyrus Malus (apple) Fruit C12-15 Alkyl Benzoate Laureth-7 Arachidyl Glucoside .alpha.-tocopherol Acetate, D- Behenyl Alcohol Avena Sativa (oat) Kernel Oil Water Squalane Glycerin Cetearyl Alcohol Ceteareth-20 Polyglyceryl-3 Stearate Polyglyceryl-4 Caprate Polyglyceryl-6 Ricinoleate 3-o-ethyl Ascorbic Acid Matricaria Chamomilla Flowering Top Oil Ethylhexylglycerin Peg-100 Stearate Arachidyl Alcohol Sodium Hydroxide Sodium Hyaluronate Coco-glucoside Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Citric Acid Avena Sativa (oat) Bran Sodium Benzoate Guar Hydroxypropyltrimonium Chloride .alpha.-tocopherol Acetate Citrus Aurantium Dulcis (orange) Peel Oil Sodium Cocoyl Isethionate Gluconolactone Cocamidopropyl Betaine Ascorbyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-14
Description

Salicylic acid 1.5%

Purpose

Acne treatment

Medication Information

Purpose

Acne treatment

Description

Salicylic acid 1.5%

Use

for treatment of acne

Warnings

For external use only

Directions
  • Use every morning and evening
  • Apply a dime-size amount to damp skin and gently massage, avoiding eye area
  • Rinse well
  • Use wash on entire affected area one to two times daily
  • May be used on chest or back
Kit 80861 118

Active Ingredient

Salicylic acid 1.5%

Active Ingredient

Salicylic acid 1.5%

Inactive Ingredients

water, cocamidopropyl betaine, sodiumcocoyl

isethionate, glycerin, coco-glucoside, acrylates/Cl 0-30 alkyl acrylate crosspolymer, sodium

hydroxide, sodium benzoate, guar hydroxypropyltrimonium chloride, tocopheryl acetate, sodium

hyaluronate, ascorbyl palmitate, citric acid, gluconolactone, chamomilla recutita (matricaria)

flower extract, avena sativa (oat) bran extract, citrus aurantium dulcis (orange) peel extract

Acne Lotion 80861 119

Questions Or Comments?

1-888-768-2913

Acne Cleanser 80861 008

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.

If contact occurs, rinse thoroughly with water

1. When Using This Product

1. skin initation and dryness is more likely to occur r

you use another topical acne medic,rnon at the same time. If irritation occurs, only use one topical

acne medication at a time.

2. If contact occurs, rinse thoroughly with water

Keep Out of Reach of Children

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

Structured Label Content

Use

for treatment of acne

Purpose

Acne treatment

Warnings

For external use only

Directions
  • Use every morning and evening
  • Apply a dime-size amount to damp skin and gently massage, avoiding eye area
  • Rinse well
  • Use wash on entire affected area one to two times daily
  • May be used on chest or back
Kit 80861 118 (Kit 80861-118)

Active Ingredient

Salicylic acid 1.5%

Active Ingredient (Active ingredient)

Salicylic acid 1.5%

Inactive Ingredients (Inactive ingredients)

water, cocamidopropyl betaine, sodiumcocoyl

isethionate, glycerin, coco-glucoside, acrylates/Cl 0-30 alkyl acrylate crosspolymer, sodium

hydroxide, sodium benzoate, guar hydroxypropyltrimonium chloride, tocopheryl acetate, sodium

hyaluronate, ascorbyl palmitate, citric acid, gluconolactone, chamomilla recutita (matricaria)

flower extract, avena sativa (oat) bran extract, citrus aurantium dulcis (orange) peel extract

Acne Lotion 80861 119 (Acne lotion 80861-119)

Questions Or Comments? (Questions or comments?)

1-888-768-2913

Acne Cleanser 80861 008 (Acne cleanser 80861-008)

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.

If contact occurs, rinse thoroughly with water

1. When Using This Product (1. When using this product)

1. skin initation and dryness is more likely to occur r

you use another topical acne medic,rnon at the same time. If irritation occurs, only use one topical

acne medication at a time.

2. If contact occurs, rinse thoroughly with water

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:32.945263 · Updated: 2026-03-14T23:09:23.715399