Label: SANITIZING WIPES- alcohol 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 July 23, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antimicrobial

  • Use

    To help reduce microbes on the skin.

  • Warnings

    • For external use only.
    • Do not dispose of wipes in flush toilets.
    • Flammable: Keep away from fire or flame.
  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop using and ask a doctor if: irritation or redness develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

  • Directions

    Apply to hands or skin. No rinsing required. Discard after use.

  • Other information

    • Store below 110 °F（43° C).
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water(Aqua).

  • Package Label - Principal Display Panel

    20pcs NDC: 74934-031-01 20pcs label

    75pcs NDC: 74934-031-02 75pcs label

  • INGREDIENTS AND APPEARANCE
    SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74934-031
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74934-031-0120 in 1 BOX07/23/2020
    11 in 1 PACKET
    13.915 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:74934-031-0275 in 1 BOX07/23/2020
    21 in 1 PACKET
    23.915 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/23/2020
    Labeler - Zhejiang iColor Biotech Co., Ltd (554528308)
    Establishment
    NameAddressID/FEIBusiness Operations
    WESSCO International118553619label(74934-031)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang iColor Biotech Co., Ltd554528308manufacture(74934-031)
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