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

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

View All Sections
  • Active Ingredient(s)

    Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • 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 and flame

  • Do not use

    • on open wounds or near eyes. In case of contact with eyes, rinse thoroughly with water.
  • WHEN USING

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

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

  • STOP USE

    Doscontinue use if irritation or rash develops. If condition 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, green tea, glycerin,carbomer, cardamom oil, lavender oil, sodium hydroxide, water

  • Package Label - Principal Display Panel

    PAH Label 80335-110-0260 mL NDC: 80335-110-02

  • INGREDIENTS AND APPEARANCE
    PLANEAIRE HANDS HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80335-110
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)  
    CARDAMOM OIL (UNII: JM0KJ091HZ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80335-110-0260 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!