30 DAY ACNE TREATMENT KIT- salicylic acid, benzoyl peroxide kit

30 day Acne Treatment Kit by

Drug Labeling and Warnings

30 day Acne Treatment Kit by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Acne Cleanser

Active ingredients Purpose

Salicylic Acid 0.5% Acne Medication

Acne Lotion

Active Ingredient Purpose

Benzoyl Peroxide 5% Acne treatment

PURPOSE

Use - For the Treatment of acne

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if irritation becomes severe.

Acne Cleanser

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 medication at a time.
• Avoid contact with eyes, If contact occurs, flush thoroughly with water.

Acne Lotion

Warnings:

• For external use only
• Do not use if you
• have very sensitive skin
• are sensitive to benzoyl peroxide.
• 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 medication at a time
• Avoid unnecess sun exposure and use a sunscreen
• Avoid contact with eyes, lips and mouth
• Avoid contact with hair and dyed fabrics, which may be bleached by this product
• Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in lower concentration.

Acne Cleanser

Directions:

• Cleanse twice a day.
• Wet face. Apply to hands, add water and work into lather.
• Massage Face gently.
• Rinse thoroughly.

Acne Lotion

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 directed by a doctor
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day
• If going outside, apply a sunscreen after using this product
• If irritation or sensitivity develops, stop use of both products and ask a doctor

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.

PRINCIPAL DISPLAY PANEL

Organiclear Acne Kit

INGREDIENTS AND APPEARANCE

30 DAY ACNE TREATMENT KIT 
salicylic acid, benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-0250

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-0250-1	1 in 1 KIT; Type 0: Not a Combination Product	08/23/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	90 mL
Part 2		1
Part 3	1 TUBE	180 mL

Part 1 of 3

ORGANICLEAR ACNE 
benzoyl peroxide lotion

Product Information
Item Code (Source)	NDC: 56152-0251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-0251-1	90 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	08/23/2023

Part 2 of 3

ORGANICLEAR SOOTHING LOTION 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
INGR	WATER (UNII: 059QF0KO0R)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
INGR	SANTALUM SPICATUM WHOLE (UNII: O8PUT104O1)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	LACTIC ACID (UNII: 33X04XA5AT)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/24/2023

Part 3 of 3

ORGANICLEAR ACNE CLEANSER 
salicylic acid cream

Product Information
Item Code (Source)	NDC: 56152-0252
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-0252-1	180 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	08/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	08/23/2023

Labeler - Cosmetic Enterprises Ltd (017701475)