Label: HAND SANITIZING WIPES- alcohol cloth

  • NDC Code(s): 75127-006-01, 75127-006-02, 75127-006-03, 75127-006-04, view more
    75127-006-05, 75127-006-06, 75127-006-07, 75127-006-08, 75127-006-09, 75127-006-10
  • Packager: Jurong Dongfa General Merchandise Co., Ltd.
  • 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 February 24, 2022

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  • Drugs Fact

  • Active ingredient

    Alcohol 65.9% by volume

    Purpose

    Antiseptic

  • Uses:

    • For hand sanitizing to decrease bacteria on the skin.
      Apply topically to the skin to help prevent cross contamination.Recommended for repeated use.
      ·Dries in seconds.
  • Warnings

    • Flammable, keep away from fire or flame. For external use only.Do not use in or contact the eyes.
      Discontinue use if redness or irritation develops.
      · If condition persists for more than 72 hours, consult a physician.· Keep out of reach of children unless under adult supervision.

    Keep this out of reach of children.

    • Keep out of reach of children unless under adult supervision.
  • Directions

    • Remove lid.
      Pull wipe from center of roll and thread through opening in lid. Do notpush finger through opening.
      Replace lid, pull wipe up, and then out at 45° angle. The next wipe dispenses automatically.
      Close lid to retain moisture.
  • Inactive ingredients

    Water, Propylene Glycol, Glycerin,Carbomer,Aminomthyl Propanol AloeBarbadenis Leaf Juice,Tocopheryl Acetate.

  • Package Labeling:

    1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75127-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.659 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75127-006-01200 in 1 CARTON10/10/2020
    110 in 1 BAG
    14.32 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:75127-006-026 in 1 CARTON10/10/2020
    2240 in 1 PAIL
    24.32 mL in 1 PATCH; Type 0: Not a Combination Product
    3NDC:75127-006-0324 in 1 CARTON10/10/2020
    380 in 1 BAG
    34.32 mL in 1 PATCH; Type 0: Not a Combination Product
    4NDC:75127-006-044 in 1 CARTON10/10/2020
    4800 in 1 BAG
    44.32 mL in 1 PATCH; Type 0: Not a Combination Product
    5NDC:75127-006-054 in 1 CARTON10/10/2020
    51200 in 1 BAG
    54.32 mL in 1 PATCH; Type 0: Not a Combination Product
    6NDC:75127-006-068 in 1 CARTON10/10/2020
    6200 in 1 PAIL
    64.32 mL in 1 PATCH; Type 0: Not a Combination Product
    7NDC:75127-006-07200 in 1 CARTON10/10/2020
    715 in 1 BAG
    74.32 mL in 1 PATCH; Type 0: Not a Combination Product
    8NDC:75127-006-0840 in 1 CARTON10/10/2020
    850 in 1 BAG
    84.32 mL in 1 PATCH; Type 0: Not a Combination Product
    9NDC:75127-006-0912 in 1 CARTON10/10/2020
    9240 in 1 PAIL
    94.32 mL in 1 PATCH; Type 0: Not a Combination Product
    10NDC:75127-006-104 in 1 CARTON10/10/2020
    101500 in 1 BAG
    104.32 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 finalpart333E10/10/2020
    Labeler - Jurong Dongfa General Merchandise Co., Ltd. (528077612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jurong Dongfa General Merchandise Co., Ltd.528077612manufacture(75127-006)
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