Label: MISS SPA- hand sanitiser gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 14, 2013

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  • Miss Spa Hand Sanitiser

    ACTIVE INGREDIENT: ETHYL ALCOHOL 55.4% PURPOSE ANTISEPTIC

    ANTISEPTIC

    USES: TO HELP REDUCE BACTERIA ON THE HANDS.

    WARNING: FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

    WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES AND LIPS. IF CONTACT OCCURS, RINSE WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS

    KEEP OUT OF REACH OF CHILDREN, IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    DIRECTIONS: WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

    INACTIVE INGREDIENTS: WATER, PROPYLENE GLYCOL, FRAGRANCE, POLYACRYLIC ACID, HYDROGENATED JOJOBA OIL, ALOE BARBADENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, DISODIUM EDTA, SODIUM HYDROXIDE. MAY CONTAIN: FD&C BLUE NO. 1(CI 42090), D&C RED NO. 33(CI 17200), FD&C RED NO. 40(CI 16035), FD&C YELLOW NO. 5 (CI 19140)

  • Miss Spa Hand Sanitiser

    image description
  • INGREDIENTS AND APPEARANCE
    MISS SPA  
    hand sanitiser gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61238-1125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL554 mL  in 554 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) (UNII: 12GIN16K1G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)  
    DISODIUM (ETHOXYCARBONYL)PHOSPHONATE (UNII: 0YFB1C22IN)  
    SODIUM HYDRIDE (UNII: 23J3BHR95O)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61238-1125-129 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/15/2013
    Labeler - Oriental Home Sense Co., Ltd. (668448004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oriental Home Sense Co., Ltd.668448004manufacture(61238-1125)
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