Label: AIR AND WATER SUGAR PLUM HAND SANITIZER- alcohol liquid

  • 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 October 17, 2020

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  • ACTIVE INGREDIENT

    Active ingredient               Ethyl Alcohol       ...........         70% v/v

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center right away.

  • INDICATIONS & USAGE

    • To decrease bacteria on the skin that could cause disease
    • When water, soap and towel are not available. 
    • recommended for repeated use
  • WARNINGS

    For external use only
    Flammable. Keep away from fire or flame.

    When using this product 

    • Keep out of eyes, ears or mouth 
    • In case of eye contact, flush eyes with water.
    • Avoid contact with broken skin.
    • Do not inhale or ingest

    Stop use and ask a doctor If

    • Redness or irritation develops.
    • Condition persists for more than 72 hours

    Other information:

    • Store under 105℉ (40℃).
    • May discolor certain fabrics.
    • Harmful to wood finishes and plastics.
  • Directions:

    • Wet hands thoroughly with product and allow to dry without wiping.
    • No rinsing required.
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.
  • INACTIVE INGREDIENT

    Water (Aqua), Triethanolamine, Carbomer, Aloe Bardadensis Leaf Extract, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E). Main Contain: FD & C Red 40 (Cl 16035), FD & C Yellow 6 (Cl 15985), FD& C Violet 2 (Cl 60725), FD& C Blue 1 (Cl 42090), FD & C Yellow 5 (Cl 19140), FD& C Red 33 (Cl 17200).

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    AIR AND WATER SUGAR PLUM HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74149-043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containFD&C RED NO. 40 (UNII: WZB9127XOA)  
    May containFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    May containD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74149-043-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2020
    2NDC:74149-043-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/17/2020
    Labeler - Yiwu Yangjie Daily Chemicals Co.,Ltd. (529648827)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Yangjie Daily Chemicals Co.,Ltd.529648827manufacture(74149-043)
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