OCEAN SEAS DERMATOLOGY ACNE TREATMENT CLEANSER (BENZOYL PEROXIDE) SOLUTION [COASTAL CAROLINAS INTEGRATED MEDICINE]

OCEAN SEAS DERMATOLOGY ACNE TREATMENT CLEANSER (BENZOYL PEROXIDE) SOLUTION [COASTAL CAROLINAS INTEGRATED MEDICINE]
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NDC 69627-112-03
Set ID d11cde63-2276-4fc7-ad87-e696d3aa7a22
Category HUMAN OTC DRUG LABEL
Packager Coastal Carolinas Integrated Medicine
Generic Name
Product Class
Product Number
Application Number PART333D
  • Active ingredient

    Benzoyl Peroxide 2.5%

  • Purpose

    Acne Treatment

  • Uses

    for treatment of acne

  • Warnings

    For external use only

  • Do Not Use

    • if you have very sensitive skin • are sensitive to benzoyl peroxide.

  • 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

    • if irritation becomes severe.

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Use every evening. Wet face with water. Apply a dime-sized amount into hands and gently wash your face; take care to avoid the eye area. Rinse well. • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of product and ask a doctor.

  • 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

  • Questions or Comments

    1-844-88OCEAN (6-2326)

  • Package/Label Principal Display Panel

    OCEAN SEAS™
    DERMATOLOGY

    ACNE
    TREATMENT
    CLEANSER

    Distributed by OCEAN SEAS DERMATOLOGY
    North Myrtle Beach, SC 29597

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    OCEAN SEAS DERMATOLOGY ACNE TREATMENT CLEANSER 
    benzoyl peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69627-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69627-112-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/29/2016
    Labeler - Coastal Carolinas Integrated Medicine (007485606)
    Registrant - Coastal Carolinas Integrated Medicine (007485606)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. J SkinClinic, Inc.101497332MANUFACTURE(69627-112) , ANALYSIS(69627-112) , LABEL(69627-112)

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