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 July 16, 2020

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  • Active Ingredient(s)

    Alcohol 75%. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    • 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

    If swallowed, get medical help or contact a poison control center immediately

  • DO NOT USE

    Do not use in eyes. In case of contact, rinse thoroughly with water.

  • STOP USE

    Stop use and ask doctor if rash/redness or irritation appears/develops and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center

  • Directions

    • Open lid, gently pull back resealable label, remove and use wipe as required.
    • Reseal back after use to avoid evaporation of alcohol.
  • Inactive ingredients

    water

  • Package Label - Principal Display Panel

    79014-002-02 10PCS

    PDP

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79014-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79014-002-0150 in 1 BAG07/15/202007/15/2020
    13.5 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:79014-002-0210 in 1 BAG07/15/2020
    23.5 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 finalpart333A07/15/2020
    Labeler - Wenzhou Bofeng Packaging Co., Ltd. (414123871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wenzhou Bofeng Packaging Co., Ltd.414123871manufacture(79014-002)
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