Label: OCEAN SEAS DERMATOLOGY ACNE TREATMENT CLEANSER- benzoyl peroxide solution
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Contains inactivated NDC Code(s)
NDC Code(s): 69627-112-03 - Packager: Coastal Carolinas Integrated Medicine
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 28, 2016
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- Active ingredient
- Purpose
- Uses
- Warnings
- Do Not Use
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When Using This Product
• avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, 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 a lower concentration
- Stop and Ask a Doctor
- Keep Out of Reach of Children
- Directions
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Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, * Camellia Sinensis (Green Tea) Leaf Extract, * Fragrance, Ginkgo Biloba (Ginkgo) Leaf Extract, * Glycerin, * Glycerin* (and) Cucumis Sativus (Cucumber) Fruit Extract, * Morus Alba (Mulberry) Bark Extract, * Sodium C14-16 Alpha Olefin Sulfonate, Sodium Hydroxide, Phenoxyethanol (and) Methylisothiazolinone, Water. *organic
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INGREDIENTS AND APPEARANCE
OCEAN SEAS DERMATOLOGY ACNE TREATMENT CLEANSER
benzoyl peroxide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69627-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CUCUMBER (UNII: YY7C30VXJT) GINKGO (UNII: 19FUJ2C58T) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MORUS ALBA BARK (UNII: 7O71A48NDP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69627-112-03 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 03/29/2016 Labeler - Coastal Carolinas Integrated Medicine (007485606) Registrant - Coastal Carolinas Integrated Medicine (007485606) Establishment Name Address ID/FEI Business Operations Dr. J SkinClinic, Inc. 101497332 MANUFACTURE(69627-112) , ANALYSIS(69627-112) , LABEL(69627-112)
