Label: PLANEAIRE HANDS HAND SANITIZER- ethyl 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 October 7, 2021

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  • SPL UNCLASSIFIED SECTION

    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 World Health Organization (WHO) recommendations:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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
    3. Sterile distilled water or boiled cold water
    4. Other inactive ingredients.
  • Active Ingredient(s)

    Alcohol 70% v/v.

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

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

  • Warnings

    For external use only- on hands. Flammable. Keep away from heat or flame

  • Do not use

    • on open wounds or near eyes.
  • WHEN USING

    In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use if irritation or rash occurs. If conditon persists for more than 72 hours, consult a doctor

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

  • STOP USE

    Stop use if irritation or rash occurs. If conditon persists for more than 72 hours, consult a doctor

  • 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

    • Wet hands thoroughly with product, rub hands, and allow to dry without wiping
    • For children under 6 years of age, use only under adult supervision to avoid swallowing
    • not recommended for infants
  • Other information

    • store between 15-30C (59-86F)
    • do not store above 105F
    • avoid freezing
    • may discolor some fabrics
    • may be harmful to some wood finishes and plastics
  • Inactive ingredients

    aloe vera inner leaf, green tea extract, carbomer, glycerin, lemon oil, carrot seed oil, sodium hydroxide, water

  • Package Label - Principal Display Panel

    PAH Label 80335-106-0260 mL NDC: 80335-106-02

  • INGREDIENTS AND APPEARANCE
    PLANEAIRE HANDS HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80335-106
    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
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LEMON OIL (UNII: I9GRO824LL)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80335-106-0260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/21/2020
    Labeler - EverywhereAire LLC (117635273)
    Registrant - EverywhereAire LLC (117635273)
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