Label: ALCOHOL WIPES- alcohol cloth

  • NDC Code(s): 71734-202-01
  • Packager: JIANGMEN SHUIZIRUN SANITARY ARTICLES 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 October 9, 2017

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Ethyl Alcohol 31% (v/v)

  • Purpose

    Antiseptic

  • Uses:

    • To decrease bacterial on the skin that could cause disease.
    • Clean and refresh hands and face.
  • WARNINGS

    For external use only.

    • Flammable, keep away from heat and flame.
    • When using this product, keep out of eyes. In case of eye contact, flush thoroughly with water.
    • Avoid contact with broken skin.
    • Do not inhale or ingest.
    • Stop use and ask a doctor if skin irritation develops.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions:

    • Wet hands and face thoroughly with product and allow to dry without wiping
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.

    Other Information:

    • do not store above 105 F.
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive Ingredients:

    alcohol, water, acetone, phenylphenol, triethanolamine, poly methacrylate, essence

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Case Label

    Alcohol WIPES

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol.31 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-202-013.6 mL in 1 PACKAGE; Type 0: Not a Combination Product10/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/09/2017
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534MANUFACTURE(71734-202)
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