Label: SANITIZERX SANITIZING WIPES cloth

  • 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 June 29, 2020

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  • Active Ingredient(s)

    Ethanol Alcohol 75%

  • Purpose

    /

  • Use

    For hand cleaning to decrease bacteria on the skin. May be used on hand, arms and legs

  • Warnings

    For extemal use only.
    Flammable. Keep away from heat or flame

  • Do not use

    /

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For use apply thoroughly to hands and skin as desired. Discard wipe in trash receptacle after use. Do not flush. Keep the package opening securely shut to prevent the wipes from drying out

  • Inactive ingredients

    Purified water, Aloe vera extract, Honeysuckle extract, Nonwoven fabric

  • Package Label - Principal Display Panel

    5010

  • INGREDIENTS AND APPEARANCE
    SANITIZERX SANITIZING WIPES 
    sanitizerx sanitizing wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42129-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LONICERA DASYSTYLA WHOLE (UNII: XBP82323JY)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42129-013-0110 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:42129-013-0250 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Fustin(Xiamen) Commodity Co., ltd (421291161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fustin(Xiamen) Commodity Co., ltd421291161manufacture(42129-013)
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