Label: 75% ALCOHOL WIPES- alcohol cloth

  • NDC Code(s): 81614-075-20, 81614-075-50
  • Packager: Orange (Fujian) Sanitary Products 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 22, 2021

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  • Active Ingredient(s)

    ALCOHOL75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, 75% ALCOHOL WIPES

  • Use

    USES:Single use wipes to cleanse hands and help prevent the spread of bacteria.

  • Warnings

    • For external use only.
    • Do not replace wipes used for medical procedures.
    • These wipes are meant for general cleansing.
    • Flammable. Keep away fire or sources of heat.
    • Avoid contact with eyes.
    • If eyes contact occurs, flush eyes with water.
    • Store at room temperature 59 ℉（15℃）-86 ℉（30℃）.
  • Do not use

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

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    If irritation and redness develop. If condition continues, consult your health care practitoner.

  • 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

    • 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.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    WATER

  • Package Label - Principal Display Panel

    20 cloth NDC: 81614-075-20

    20 cloth label

    50 cloth NDC: 81614-075-50

    50 CLOTH LABEL

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81614-075
    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:81614-075-2020 in 1 PACKAGE02/17/2021
    15.75 mL in 1 PATCH; Type 0: Not a Combination Product
    2NDC:81614-075-5050 in 1 PACKAGE02/17/2021
    26 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 finalpart333A02/17/2021
    Labeler - Orange (Fujian) Sanitary Products Co., Ltd. (715236216)
    Registrant - Orange (Fujian) Sanitary Products Co., Ltd. (715236216)
    Establishment
    NameAddressID/FEIBusiness Operations
    Orange (Fujian) Sanitary Products Co., Ltd.715236216manufacture(81614-075)
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