Atrixsystem 1

Atrixsystem 1
SPL v4
SPL
SPL Set ID c8d50ce6-5580-d3ef-e053-2a95a90a01d2
Route
TOPICAL
Published
Effective Date 2021-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Water Glucosamine Hydrochloride Cyclomethicone 5 Caprylyl Glycol Stearic Acid .alpha.-tocopherol Acetate, Dl- Butylene Glycol Dimethicone Cetearyl Olivate Oligopeptide-10 Phenoxyethanol Decyl Glucoside Saccharomyces Cerevisiae Sodium Ascorbyl Phosphate Urea .alpha.-glucan Oligosaccharide Glycyrrhizinate Dipotassium Edetate Disodium Ethylhexylglycerin Hexylene Glycol Sodium Hydroxide Glycerin Glyceryl Stearate Se Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Sorbitan Olivate Palmitic Acid Laminaria Digitata Allyl Methacrylate/glycol Dimethacrylate Crosspolymer Grapefruit Oil Menthyl Lactate, (-)- Apple Rosemary .alpha.-ionene Cocamidopropyl Betaine European Elderberry Cetyl Hydroxyethylcellulose (350000 Mw) Lauryl Glucoside Menthol, Unspecified Form Sodium Lauryl Glycol Carboxylate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-10-25

Description

Salicylic Acid 2%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 2%

Use

■ 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

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

Atrix™

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.

Questions?

Call toll-free:

1-877-921-7873

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

Use

■ 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

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

Atrix™

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.

Questions?

Call toll-free:

1-877-921-7873

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.


Advanced Ingredient Data


Raw Label Data

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