ATRIX SYSTEM 1- salicylic acid 
PureTek Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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AtrixSystem 1

ATRIX ACNE TREATMENT CREAM (2 fl oz ) 59 mL
ATRIX ANTIBACTERIAL WASH (4 fl oz ) 118 mL



10/19- update marketing date

Atrix™ Acne Treatment Cream (2 fl oz ) 59 mL

Drug Facts

Active ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

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

Warnings

For external use only

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.

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.

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

Call toll-free:

1-877-921-7873

Atrix™ Antibacterial Wash (4 fl oz ) 118 mL

Active ingredient

Salicylic Acid 2%

Purpose

Acne treatment

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

Warnings

For external use only.

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.

Directions

■ Cleanse twice a day.

■ Wet face. Apply to hands, add water and work into a lather.

■ Massage face gently.
■ Rinse thoroughly and pat dry if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Use under the direction of a medical practitioner.

Other information

■ protect from freezing

■ avoid excessive heat

Store at 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature].

Inactive ingredients

Aqua (Purified Water), Cetyl Hydroxyethylcellulose, Citrus Paradisi (Grapefruit) Peel Oil, Cocamidopropyl Betaine, Disodium EDTA, Ethoxydiglycol, Glycerin, Lauryl Glucoside, Menthol, Menthyl Lactate, Pyrus Malus (Apple) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sambucus Nigra (Elderberry) Fruit Extract, Sodium Lauryl Glucose Carboxylate.

Questions?

Call toll-free:

1-877-921-7873

Atrix™ System

Label

ATRIX SYSTEM 1 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-713
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-713-001 in 1 KIT; Type 0: Not a Combination Product10/25/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 59 mL
Part 21 BOTTLE 118 mL
Part 1 of 2
ATRIX ACNE TREATMENT 
salicylic acid cream
Product Information
Item Code (Source)NDC:59088-446
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
UREA (UNII: 8W8T17847W)  
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PALMITIC ACID (UNII: 2V16EO95H1)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: B9J55EA6QX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-446-0559 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/06/2021
Part 2 of 2
ATRIX ANTIBACTERIAL WASH 
salicylic acid liquid
Product Information
Item Code (Source)NDC:59088-445
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GRAPEFRUIT OIL (UNII: YR377U58W9)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
APPLE (UNII: B423VGH5S9)  
ROSEMARY (UNII: IJ67X351P9)  
.ALPHA.-IONENE (UNII: B2ZN1K7W3Q)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
WATER (UNII: 059QF0KO0R)  
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-445-08118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/25/2021
Labeler - PureTek Corporation (785961046)

Revised: 1/2023
Document Id: f2052af0-ff59-a86b-e053-2a95a90a970a
Set id: c8d50ce6-5580-d3ef-e053-2a95a90a01d2
Version: 3
Effective Time: 20230111
 
PureTek Corporation