PLANEAIRE HANDS HAND SANITIZER- ethyl alcohol gel 
EverywhereAire LLC

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.

----------

PlaneAire Hands gel Lemon Carrotseed hand sanitizer

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

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 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.

Directions

Other information

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

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)

Revised: 10/2021
Document Id: cdccc6db-e004-840f-e053-2a95a90a3bcf
Set id: b68a5d56-1a0d-755c-e053-2995a90a3954
Version: 2
Effective Time: 20211007
 
EverywhereAire LLC