Label: ONE DROP CARE HAND DISINFECTANT- alcohol gel

  • 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 April 17, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Alcohol 75% 

  • Purpose

    Antiseptic

  • Use

    Sterilizing and cleaning hands, skin, and daily necessites

  • Warnings

    For external use only. Flammable. Keep away from open flame and sources of heat

  • Do not use

    Do not use 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

    Stop use if irritation or rash occurs. If condition persists contact a healthcare pratitioner

  • 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

    Apply to intended area as needed

  • Other information

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

    Purified Water, Glycerin, Aloe Barbadensis Extract, Propylene Glycerol, Triethanolamine, Tocopherol (Vitamin E), Carbomer, Colloidal Silver, Parfum

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    ONE DROP CARE HAND DISINFECTANT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75226-004
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE ANDONGENSIS WHOLE (UNII: XOQ5N25YKS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75226-004-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    2NDC:75226-004-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    3NDC:75226-004-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    4NDC:75226-004-04300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    5NDC:75226-004-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/17/2020
    Labeler - Guangzhou Wantuo Biotechnology Co. LTD (418639838)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGDONG JUNBAO INDUSTRY CO., LTD543255690manufacture(75226-004)
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