Label: 30 DAY ACNE TREATMENT KIT- salicylic acid, benzoyl peroxide kit
- NDC Code(s): 56152-0250-1, 56152-0251-1, 56152-0252-1
- Packager: Cosmetic Enterprises Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 4, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Acne Cleanser
- Acne Lotion
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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.
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Acne Lotion
Warnings:
- For external use only
- Do not useif 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
-
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.
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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
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INGREDIENTS AND APPEARANCE
30 DAY ACNE TREATMENT KIT
salicylic acid, benzoyl peroxide kitProduct 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 lotionProduct 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 Drug M006 08/23/2023 Part 2 of 3 ORGANICLEAR SOOTHING LOTION
body and hand (excluding shaving preparations), leave-on [skin care preparations (creams, lotions, powder, and sprays)] lotionProduct 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 creamProduct 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 Drug M006 08/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 08/23/2023 Labeler - Cosmetic Enterprises Ltd (017701475)