Label: ALCOHOL 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 August 12, 2020

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

  • ACTIVE INGREDIENT

    Ethyl Alcohol 75%

    Antiseptic

  • USE

    Use: Health care personnel hand rub to help
    reduce bacteria that potentially can cause disease.

  • Warning

    For external use only. Flammable.
    Keep away from heat or flame.
    Do not use
    ●in children less than 2 months of age
    ●on open skin wounds
    When using this product
    ●keep out of eyes, ears, and mouth.
    ●if case of contact with eyes, rinse
    eyes thoroughly with water
    Stop use and ask a doctor if
    ●irritation and redness develop. These
    may be signs of a serious condition.

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

  • Directions

    Directions●Place enough product on
    hands to cover all surfaces. Rub hands
    together until dry.
    ●Supervise children under 6 years of age
    when using this product to avoid swallowing.

  • Inactive ingredients

    25% Pure Water

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78536-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78536-003-0512 in 1 CARTON07/07/2020
    1150 in 1 BAG
    1810 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:78536-003-0930 in 1 CARTON07/07/2020
    2100 in 1 BOTTLE
    2540 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:78536-003-1030 in 1 CARTON07/07/2020
    380 in 1 BOTTLE
    3432 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    4NDC:78536-003-0324 in 1 CARTON07/07/2020
    484 in 1 BAG
    4454 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    5NDC:78536-003-0612 in 1 CARTON07/07/2020
    5160 in 1 BAG
    5864 mL in 1 POUCH; Type 0: Not a Combination Product
    6NDC:78536-003-0412 in 1 CARTON07/07/2020
    6140 in 1 BAG
    6756 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    7NDC:78536-003-0712 in 1 CARTON07/07/2020
    7170 in 1 BAG
    7918 mL in 1 POUCH; Type 0: Not a Combination Product
    8NDC:78536-003-0812 in 1 CARTON07/07/2020
    8180 in 1 BAG
    8972 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    9NDC:78536-003-0124 in 1 CARTON07/07/2020
    948 in 1 BAG
    9260 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    10NDC:78536-003-0224 in 1 CARTON07/07/2020
    1064 in 1 BAG
    10346 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/07/2020
    Labeler - Zhejiang Yiwu Mingou Biotechnology Co., Ltd. (554535538)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Yiwu Mingou Biotechnology Co., Ltd.554535538manufacture(78536-003)