Label: RENARDBLANC ACNE CLEANSING BAR- salicylic acid soap

  • 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 17, 2020

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  • ACTIVE INGREDIENT

    Salicylic Acid 0.6%

  • PURPOSE

    Acne Treatment

  • INDICATIONS & USAGE

    For the treatment of Acne

  • DOSAGE & ADMINISTRATION

    Wet face. Gently massage product all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Recommended for daily use.

  • 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 acne medication at a time. avoid contact with eyes. If contact occurs, flush thoroughly with water.
    People with allergy to aspirin will react poorly to the Salicylic Acid.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Sekken Soji, Hydrolyzed Corn Starch, Cocamidopropyl Dimethylamine, Polyquaternium-67, Hydrated Silica, Butyrospermum Parkii (Shea) Butter, Cirsium (Thistle) Extract, Houttuynia Cordata Extract, Centella Asiatica Extract, Melaleuca Alternifolia (Tea Tree) Extract, Cocos Nucifera (Coconut) Oil, Hydrogenated Jojoba Oil, Vitis Vinifera (Grape) Seed Oil, Olea Europaea (Olive) Fruit Oil, Hydrolyzed Hyaluronic Acid, Allantoin, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RENARDBLANC ACNE CLEANSING BAR 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72073-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72073-003-01100 g in 1 CARTON; Type 0: Not a Combination Product06/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/11/2018
    Labeler - Diamonie Seoul Cosmetic Co Ltd (694502893)
    Registrant - Diamonie Seoul Cosmetic Co Ltd (694502893)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASAN C&S631139649manufacture(72073-003)
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