Label: PREVICARE HYSSOP SANITIZER- alcohol gel
PREVICARE HOLY WATER PLUS HYSSOP SANITIZER- 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 February 10, 2021

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% V/V

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame. Do not ingest. Do not use if you are allergic to any ingredient.

    Keep out of reach of children. If swallowed, get medical help. Do not use on open wounds. When using ths product avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water. Stop use and ask a doctor if irritation develops.

  • Directions

    Apply to one palm, rub hands together until dry. Use as part of your daily cleaning routine. Do not rinse with water. Do not dilute the product. Supervise children when using this product.

  • Other Information

    Store at 50-86°F (15-30°C).

  • Inactive Ingredients

    Aqua (purified water), Hyssop and Rosemary Mint Oil, Glycerin, Aloe Barbadensis (Aloe) Leaf Juice, PEG-75 Lanolin, PEG-7 Glyceryl Cocoate (emollient), Myristyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine.

  • Questions?

    Call 1 (716) 427-7979

  • SPL UNCLASSIFIED SECTION

    Distributed by: Previcare Pharmaceutical, Inc.
    50 Fountain Plaza • Suite 1400 • Buffalo • NY • 14202 • USA

  • PRINCIPAL DISPLAY PANEL - 60 ML Bottle Label - NDC 73401-849

    PREVICARE
    SANITIZER GEL | 70% ALCOHOL

    HYSSOP

    2 FL OZ (60 ML)

    NDC 73401-849-09

    Principal Display Panel - 60 ML Bottle Label - NDC 73401-849
  • PRINCIPAL DISPLAY PANEL - 60 ML Bottle Label - NDC 73401-850

    PREVICARE
    SANITIZER GEL | 70% ALCOHOL

    HOLY WATER
    + HYSSOP

    2 FL OZ (60 ML)

    NDC 73401-850-09

    Principal Display Panel - 60 ML Bottle Label - NDC 73401-850
  • INGREDIENTS AND APPEARANCE
    PREVICARE   HYSSOP SANITIZER
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73401-849
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    HYSSOP OIL (UNII: 173D71924B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73401-849-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
    2NDC:73401-849-1060 mL in 1 BOTTLE; Type 0: Not a Combination Product02/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A02/15/2021
    PREVICARE   HOLY WATER PLUS HYSSOP SANITIZER
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73401-850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    HYSSOP OIL (UNII: 173D71924B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73401-850-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2021
    2NDC:73401-850-1060 mL in 1 BOTTLE; Type 0: Not a Combination Product02/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A02/15/2021
    Labeler - Previcare Pharmaceutical, Inc. (117180835)
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