INSTANT HAND SANITIZER- alcohol gel 
FORMIA Airline Supplies Ltd

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.

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Instant Hand Sanitizer

DRUG FACTS

Active Ingredient

Ethyl alcohol 70% (v/v)

Purpose

Antibacterial

Use

-To help reduce bacteria on the skin.

Warnings

- For external use only. Flammable. Keep away from fire or flame. If swallowed, get medical help immediately.

When using this product

- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if

Irritation or redess develops and lasts.

Keep out of reach of children.

- In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

- Apply a significant amount on your palm/skin and rub until dry. Do not rinse.

Other information

- Store at room temperature.

Inactive ingredients

- Aqua(Water), Glycerin, Acylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Triethanolamine, Parfum(Fragrance).

Package Labeling:5ml

Label

Package Labeling:10ml

Label2

INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79940-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79940-000-015 mL in 1 BAG; Type 0: Not a Combination Product08/21/2020
2NDC:79940-000-0210 mL in 1 TUBE; Type 0: Not a Combination Product08/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/21/2020
Labeler - FORMIA Airline Supplies Ltd (668098317)

Revised: 8/2020
Document Id: ad531eda-e832-8769-e053-2a95a90ad41f
Set id: ad53214f-cdb2-1970-e053-2a95a90a048f
Version: 1
Effective Time: 20200820
 
FORMIA Airline Supplies Ltd