Label: PUREHOLD ANTISEPTIC INSTANT HAND SANITIZER- ethyl alcohol, isopropyl 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 September 7, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol  75%

    Isopropyl Alchool 4%

  • Purpose

    first-aid antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

  • INDICATIONS & USAGE

    Use Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    When using this product • do not get into or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Discontinue use • if irritation or redness develops • if condition persists for more than 72 hours, consult a doctor.

  • DOSAGE & ADMINISTRATION

    Directions • Apply to your hands • Rub hands together briskly until dry • Children under 6 years of age should be supervised when using this product.

  • Inactive ingredients

    Aloe Barbadensis leaf juice, 2-Amino-2-Methylpropanol, Citric acid, Glycerine, Isopropyl ester, N-Propanol, Polymer acrylates, Propylene Glycol, Tetradecanoic Acid, Tocopheryl Acetate, Triethanolamine, Water.

  • Other information

    • Store below 110°F / 43°C

    • May discolour certain fabrics or surfaces

  • Questions or comments?

    Call +44 (0) 2392 299100

    Monday to Friday 8.30 AM to 5.00 PM

  • SPL UNCLASSIFIED SECTION

    Manufacture for:

    Pure Hold Ltd.

    Unit 1

    Catherington Business Park

    Catherington Lane

    Catherington

    Hampshire

    PO8 0AQ

    United Kingdom

    www.purehold.co.uk

    Tel: +44 (0) 2392 299 100

    info@purehold.co.uk

    Manufactured by bioguard

  • Packaging

    Pur1

  • INGREDIENTS AND APPEARANCE
    PUREHOLD ANTISEPTIC INSTANT HAND SANITIZER 
    ethyl alcohol, isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70079-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL ALCOHOL (UNII: 96F264O9SV)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70079-101-01850 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2015
    Labeler - Pure Hold Ltd (219236796)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bioguard Hygiene Solutions Ltd.734370963manufacture(70079-101)
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