30 DAY ACNE TREATMENT KIT- salicylic acid, benzoyl peroxide 
Cosmetic Enterprises Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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30 day Acne Treatment Kit

Acne Cleanser

Active ingredients Purpose

Salicylic Acid 0.5% Acne Medication

Acne Lotion

Active Ingredient Purpose

Benzoyl Peroxide 5% Acne treatment

Use - For the Treatment of acne

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center immdiately.

Stop use and ask a doctor if irritation becomes severe.

Acne Cleanser

Warnings:

For external use only

when using this product

Acne Lotion

Warnings:

Acne Cleanser

Directions:

Acne Lotion

Directions:

Acne Cleanser

Inactive ingredients:

Water, Decyl Polyglucose, Laurel Glucoside, Cocamidopropyl Betaine, Glycerin, Xanthan Gum, Sodium Cocoyl Hydrolized Amaranth Protein, Malaleuca Alternifolia (Australian Tea Tree) Leaf Extract, Polysorbate 20, Backhousia Citriodora (Australian Myrtle) Leaf Extract, Fusanus Spicatus (Australian Sandalwood) Extract, Disodium EDTA.

Acne Lotion

Inactive Ingredients:

Water, Dimethicone,Cetyl Alcohol, Propylene Glycol, Polyacrylate 13/polyisobutene/ Polysorbate 20, Cocamidopropyl Betaine, Glycerin, Backhouseia Citriodora (Australian Myrtle) Leaf Extract, Fusanus Spicatus (Australian Sandalwood) Extract, Aloe Barbadensis Leaf Juice, Sodium Benzoate, Pentylene Glycol, C12-15 Alkyl Benzoate, Phenoxyethanol.

Organiclear Acne Kit

Acne Kit drug facts

30 DAY ACNE TREATMENT KIT 
salicylic acid, benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-0250
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56152-0250-11 in 1 KIT; Type 0: Not a Combination Product08/23/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 90 mL
Part 2
Part 31 TUBE 180 mL
Part 1 of 3
ORGANICLEAR ACNE 
benzoyl peroxide lotion
Product Information
Item Code (Source)NDC:56152-0251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SANTALUM SPICATUM WHOLE (UNII: O8PUT104O1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56152-0251-190 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00608/23/2023
Part 2 of 3
ORGANICLEAR SOOTHING LOTION 
lotions, oils, powders, and creams lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRMATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
INGRWATER (UNII: 059QF0KO0R)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRBACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
INGRSANTALUM SPICATUM WHOLE (UNII: O8PUT104O1)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/24/2023
Part 3 of 3
ORGANICLEAR ACNE CLEANSER 
salicylic acid cream
Product Information
Item Code (Source)NDC:56152-0252
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
WATER (UNII: 059QF0KO0R)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
SANTALUM SPICATUM WHOLE (UNII: O8PUT104O1)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56152-0252-1180 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00608/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00608/23/2023
Labeler - Cosmetic Enterprises Ltd (017701475)

Revised: 8/2023
Document Id: 039ac054-3eb3-5beb-e063-6394a90a561a
Set id: 039ac054-3eb2-5beb-e063-6394a90a561a
Version: 1
Effective Time: 20230823
 
Cosmetic Enterprises Ltd