Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID fa21d384-6867-442f-8537-290a691e2520
Route
TOPICAL
Published
Effective Date 2024-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg) Benzoyl Peroxide (5 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Decyl Glucoside Glycerin Sodium Chloride Coco-betaine Sodium Hydroxide Peg-150 Pentaerythrityl Tetrastearate Citric Acid Monohydrate Hexylene Glycol Peg-6 Caprylic/capric Glycerides Zinc Gluconate Edetate Sodium Polyquaternium-47 (methacrylamidopropyltrimethylammonium Chloride-co-methyl Acrylate-co-acrylic Acid 46:8:46; 1300000 Mw) Menthol Capryloyl Salicylic Acid Sodium Benzoate Alcohol Propanediol Glycolic Acid Capryloyl Glycine Phenoxyethanol Benzyl Alcohol Ppg-26-buteth-26 Butylene Glycol Isostearyl Alcohol Pentylene Glycol Silica Carbomer Potassium Hydroxide Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s At 0.5%) Edetate Disodium Epilobium Angustifolium Flower/leaf/stem Extract

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-01
Description

Drug Facts

Purpose

Acne treatment

Medication Information

Purpose

Acne treatment

Description

Drug Facts

Use

for the treatment of acne

Uses
  • for the treatment of acne
  • dries and clears acne blemishes and allows skin to heal
Section 51945-4

Warnings

For external use only

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

water, isostearyl alcohol, glycerin, pentylene glycol, silica, carbomer, capryloyl salicylic acid, potassium hydroxide, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, epilobium angustifolium flower/leaf/stem extract

Active Ingredient

Salicylic acid 2%

Do Not Use If You
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for a week afterwards.

Inactive Ingredients

water, sodium laureth sulfate, decyl glucoside, glycerin, sodium chloride, coco-betaine, sodium hydroxide, PEG-150 pentaerythrityl tetrastearate, citric acid, hexylene glycol, PEG-6 caprylic/capric glycerides, zinc gluconate, tetrasodium EDTA, polyquaternium-47, menthol, capryloyl salicylic acid, sodium benzoate

Questions Or Comments?

1-888-577-5226

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

When Using This Product
  • skin irritation and dryness is more liekly 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.
Effaclar Clarifying Solution

Drug Facts

Stop Use and Ask A Doctor If

irritation becomes severe

Keep Out of Reach of Children.

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

Effaclar Medicated Gel Cleanser

Drug Facts

Effaclar Duo Dual Action Acne Treatment

Drug Facts

Structured Label Content

Use

for the treatment of acne

Uses
  • for the treatment of acne
  • dries and clears acne blemishes and allows skin to heal
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 the eyes
  • rinse well
Ingredients

water, isostearyl alcohol, glycerin, pentylene glycol, silica, carbomer, capryloyl salicylic acid, potassium hydroxide, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, epilobium angustifolium flower/leaf/stem extract

Active Ingredient (Active ingredient)

Salicylic acid 2%

Do Not Use If You (Do not use if you)
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information (Other information)

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for a week afterwards.

Inactive Ingredients

water, sodium laureth sulfate, decyl glucoside, glycerin, sodium chloride, coco-betaine, sodium hydroxide, PEG-150 pentaerythrityl tetrastearate, citric acid, hexylene glycol, PEG-6 caprylic/capric glycerides, zinc gluconate, tetrasodium EDTA, polyquaternium-47, menthol, capryloyl salicylic acid, sodium benzoate

Questions Or Comments? (Questions or comments?)

1-888-577-5226

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

When Using This Product (When using this product)
  • skin irritation and dryness is more liekly 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.
Effaclar Clarifying Solution

Drug Facts

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation becomes severe

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.

Effaclar Medicated Gel Cleanser

Drug Facts

Effaclar Duo Dual Action Acne Treatment

Drug Facts

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:56.844741 · Updated: 2026-03-14T23:04:17.676959