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 5, 2020

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

  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    to decrease bacterial on the skin that could cause disease

  • Warnings

    For external use only.

  • Do not use

    • if you are allergic to any of the ingredients
    • on children less than 2 years of aga unless directed by a doctor
  • When using this product

    Avoid contact with eyes and damaged skin. In case of eye contact, flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if signs of irritation or rash appear

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Lift inner seal sticker and remove wipe. Gently wipe face and hand to clean. After use, reseal the sticker to prevent the wipes from drying out.

  • Other information

    • Store at a shady, cool and dry place
    • Avoid direct sunlight and open flames
    • Wipes are insoluble in water. Please do not throw into toilet.
  • Inactive ingredients

    water

  • Package Label - Principal Display Panel

    1 PCS NDC 90017-002-01 OAK ALCOHOL

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90017-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90017-002-011 in 1 POUCH08/05/2020
    16.5 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/05/2020
    Labeler - Zhejiang quercus daily necessities Co., Ltd (554541153)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang quercus daily necessities Co., Ltd554541153manufacture(90017-002) , label(90017-002)