Label: ALLCAREU DISPOSABLE HAND SANITIZER- alcohol solution

  • 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 13, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 65% 

  • Purpose

    Antiseptic

  • Use

    To reduce bacteria on the skin that could cause disease

    Recommended for repeated use

    Use anywhere without water

  • Warnings

    For external use only -hands

    Flammable. Keep away from heat and flame

  • WHEN USING

    When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    Avoid contact with broken skin

    Do not inhale or ingest

  • STOP USE

    Discontinue if skin becomes irritated and ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingest, seek professional assistance or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and rub until dry without wiping
    • For children under 6, use only under adult supervision
    • Not recommended for infants
  • Other information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

  • Inactive ingredients

    Water, glycerin, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, triethanolamine, fragrance, PANTHENOL, LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALLCAREU DISPOSABLE HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78988-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78988-001-0189 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
    2NDC:78988-001-02354 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
    3NDC:78988-001-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/13/2020
    Labeler - JIANGSU AllCARE BIOTECH PHARMACEUTICAL CO., LTD (554534691)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGSU AllCARE BIOTECH PHARMACEUTICAL CO., LTD554534691manufacture(78988-001)
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