Acne Treatment System

Acne Treatment System
SPL v8
SPL
SPL Set ID d39ee6a2-5d65-4198-82d9-deb83471f312
Route
TOPICAL
Published
Effective Date 2018-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg) Salicylic Acid (20 mg)
Inactive Ingredients
C13-14 Isoparaffin Ethylhexylglycerin Lanolin Oil Laureth-4 Laureth-7 Magnesium Aluminum Silicate Phenoxyethanol Propylene Glycol Water Xanthan Gum Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Alcohol Citric Acid Monohydrate Disodium Cocoamphodiacetate Disodium Cocoyl Glutamate Dmdm Hydantoin Diethylene Glycol Monoethyl Ether Hexamidine Diisethionate Peg-7 Glyceryl Cocoate Peg-120 Methyl Glucose Dioleate Sodium Hydroxide Sodium Lauroyl Sarcosinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-11

Description

Salicylic Acid USP 2%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Salicylic Acid USP 2%

Use

For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.

Warnings

For external use only.

Directions

• Wet face using lukewarm water. • Gently massage over face using fingertips. • Rinse completely. • Use both morning and night or as directed by a physician. • If dryness or peeling occurs, reduce application to once a day or every other day.







Questions?

450 455 9779 1 877 484 8437

Active Ingredient

Salicylic Acid USP 2%

Other Information

Store at room temperature (15-30°C / 59-86°F).

Package Labeling:

Inactive Ingredients

Acrylates Copolymer, Alcohol, Citric Acid, Disodium Cocoamphodiacetate, Disodium Cocoyl Glutamate, DMDM Hydantoin, Ethoxydiglycol, Fragrance, Hexamidine Diisethionate, PEG-7 Glyceryl Cocoate, PEG-120 Methyl Glucose Dioleate, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Water/Eau.

When Using This Product

do not get into eyes.

Stop Use and Ask A Doctor If

excessive skin irritation develops or increases.

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Are

using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.


Structured Label Content

Use

For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.

Purpose

Acne treatment

Warnings

For external use only.

Directions

• Wet face using lukewarm water. • Gently massage over face using fingertips. • Rinse completely. • Use both morning and night or as directed by a physician. • If dryness or peeling occurs, reduce application to once a day or every other day.







Questions?

450 455 9779 1 877 484 8437

Active Ingredient (Active ingredient)

Salicylic Acid USP 2%

Other Information (Other information)

Store at room temperature (15-30°C / 59-86°F).

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Acrylates Copolymer, Alcohol, Citric Acid, Disodium Cocoamphodiacetate, Disodium Cocoyl Glutamate, DMDM Hydantoin, Ethoxydiglycol, Fragrance, Hexamidine Diisethionate, PEG-7 Glyceryl Cocoate, PEG-120 Methyl Glucose Dioleate, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Water/Eau.

When Using This Product (When using this product)

do not get into eyes.

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

excessive skin irritation develops or increases.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)

using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.


Advanced Ingredient Data


Raw Label Data

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