Label: HAND SANITIZING WIPES- alcohol patch

  • 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 September 21, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Benzalkonium chloride 0.13%. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • USES

    For sanitizing to decrease bacteria on skin

    apply topically to the skin to help prevent cross contamination

    recommended for repeated use

    dries in seconds

  • Warnings

    For external use only.

    May irritate eyes

    Keep out of reach of children unless under adult supervision

  • DO NOT USE

  • WHEN USING

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children unless under adult supervision

  • DOSAGE & ADMINISTRATION

  • STORAGE AND HANDLING

  • Inactive ingredients

    Water, Propylene Glycol,Disodium EDTA,Chloro-methyl-isothiazolinone and Methyl-isothiazolinone,Potassium Sorbate,Quatermium-15,Aloe Barbadensis Leaf Juice,Disodium Cocoamphodiacetate,Vitamin E Acetate,Polysorbate-20,Citric Acid,Fragrance.

  • Package Label - Principal Display Panel

    image descriptionimage descriptionimage descriptionimage description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING WIPES 
    alcohol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77046-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) (METHYLCHLOROISOTHIAZOLINONE - UNII:DEL7T5QRPN) METHYLCHLOROISOTHIAZOLINONE0.0009 g  in 100 g
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.0003 g  in 100 g
    BRONOPOL (UNII: 6PU1E16C9W) (BRONOPOL - UNII:6PU1E16C9W) BRONOPOL0.03 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.02 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.50 g  in 100 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.15 g  in 100 g
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) 0.15 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.20 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.05 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 g  in 100 g
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.02 g  in 100 g
    WATER (UNII: 059QF0KO0R) 98.7 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77046-009-011 in 1 PACKAGE09/21/2020
    14 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:77046-009-0230 in 1 PACKAGE09/21/2020
    24 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/21/2020
    Labeler - ZheJiang HuaShun Technology Co.,Ltd (527157837)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZheJiang HuaShun Technology Co.,Ltd527157837manufacture(77046-009)