Atrix™ Acne Treatment Cream

Atrix™ Acne Treatment Cream
SPL v3
SPL
SPL Set ID ba106b20-32aa-df90-e053-2995a90adaef
Route
TOPICAL
Published
Effective Date 2021-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Hexylene Glycol Oligopeptide-10 Phenoxyethanol Butylene Glycol Glucosamine Hydrochloride Carbomer Homopolymer, Unspecified Type Dimethicone Glycerin Glyceryl Stearate Se Laminaria Digitata Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) .alpha.-tocopherol Acetate, Dl- Cetearyl Olivate Decyl Glucoside Saccharomyces Cerevisiae Sodium Hydroxide Sorbitan Olivate Palmitic Acid Water Urea Cyclomethicone 5 Allyl Methacrylate/glycol Dimethacrylate Crosspolymer Caprylyl Glycol Stearic Acid .alpha.-glucan Oligosaccharide Sodium Ascorbyl Phosphate Glycyrrhizinate Dipotassium Edetate Disodium Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-06

Description

Salicylic Acid 2%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 2%

Uses:

■ for the treatment of acne

■ dries and clears acne pimples, acne blemishes, whiteheads and blackheads

■ helps prevent the development of new acne pimples, acne blemishes, whiteheads and blackheads

Section 53413-1

Call toll-free:

1-877-921-7873

Warnings

For external use only

Directions

■ Clean the skin thoroughly before applying this product

■ cover the entire affected area with a thin layer one to three times daily

■ because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

■ if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Use under the direction of a medical practitioner.

Atrix Acne Cream

Packaged for :

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Active Ingredient

Salicylic Acid 2%

Other Information

■ protect from freezing

■ avoid excessive heat

Store at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Avoid excessive heat. Do not use if package is damaged.

Keep this and all medication out of reach of children.

Inactive Ingredients

Allyl Methacrylates Crosspolymer, Aqua (Purified Water), Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Olivate, Cyclopentasiloxane, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizinate, Disodium EDTA, Ethylhexylglycerin, Alpha-Glucan Oligosaccharide, Glucosamine HCl, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Laminaria Digitata (Algae) Extract, Oligopeptide- 10, Palmitic Acid, Phenoxyethanol, Polysilicone-11, Saccharomyces Cerevisiae Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, DL- alpha- Tocopheryl Acetate, Urea

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.

■ rinse right away with water if it gets in eyes.

Stop Use and Ask A Doctor

■ if skin irritation occurs or gets worse

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

■ dries and clears acne pimples, acne blemishes, whiteheads and blackheads

■ helps prevent the development of new acne pimples, acne blemishes, whiteheads and blackheads

Section 53413-1 (53413-1)

Call toll-free:

1-877-921-7873

Purpose

Acne Treatment

Warnings

For external use only

Directions

■ Clean the skin thoroughly before applying this product

■ cover the entire affected area with a thin layer one to three times daily

■ because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

■ if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Use under the direction of a medical practitioner.

Atrix Acne Cream

Packaged for :

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Active Ingredient (Active ingredient)

Salicylic Acid 2%

Other Information (Other information)

■ protect from freezing

■ avoid excessive heat

Store at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Avoid excessive heat. Do not use if package is damaged.

Keep this and all medication out of reach of children.

Inactive Ingredients (Inactive ingredients)

Allyl Methacrylates Crosspolymer, Aqua (Purified Water), Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Olivate, Cyclopentasiloxane, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizinate, Disodium EDTA, Ethylhexylglycerin, Alpha-Glucan Oligosaccharide, Glucosamine HCl, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Laminaria Digitata (Algae) Extract, Oligopeptide- 10, Palmitic Acid, Phenoxyethanol, Polysilicone-11, Saccharomyces Cerevisiae Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, DL- alpha- Tocopheryl Acetate, Urea

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.

■ rinse right away with water if it gets in eyes.

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

■ if skin irritation occurs or gets worse

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.


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