Label: PAPILION HYGIENIC DISINFECTANT ANTIBACTERIAL- alcohol liquid

  • 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 28, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (0.5% v/v).
    3. Aloe Vera Leaf (0.1% v/v).
    4. Sterile distilled water

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antibacterial

  • Purpose

    Antibacterial, Papilion Hygienic Disinfactant Antibacterial Sprey

  • Uses

    Use disinfectant spray to help reduce bacteria on the skin that could cause disease.

  • Warnings

    For external use only. Flammable. Keep away from fire or flame.

  • WHEN USING

    When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • STOP USE

    Stop use and ask a doctor if irritation or redness devolops and lasts.

  • 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

    • Put enough product in your palm to cover hands and rub hands together until dry.
    • Children under 6 years should be supervised when using this product.
  • Other information

    • Store below 106 F (41 C).
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water (Aqua), Glycerin, Propylene Glycol, Aloe Barbadensis Extract.

  • Package Label - Principal Display Panel

    120 mL NDC: 79262-160-01

    120 ml label

  • INGREDIENTS AND APPEARANCE
    PAPILION HYGIENIC DISINFECTANT ANTIBACTERIAL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79262-160
    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
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.25 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79262-160-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product02/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/21/2021
    Labeler - AR KAGIT SAN. ve TIC. LTD. STI. (356385935)
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