HAND SANITIZER- alcohol gel 
Avaria Health & Beauty Corp

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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Kalaya Antiseptic Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Warnings

For external use only

Flammable. Keep away from heat and flame.

Do not use

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

Inactive ingredients

Water, Carbomer, Hyaluronic Acid, Aminomethyl Propanol ,Isopropyl Myristate

Questions or comments?

Call toll-free 1.888.829.7165

Package Label - Principal Display Panel

13.5 fl oz (400 ml)

NDC 43493-0000-0

front panel

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL280 mL  in 400 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
HYALURONIC ACID (UNII: S270N0TRQY)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43493-0000-0400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
2NDC:43493-0000-1250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
3NDC:43493-0000-260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
4NDC:43493-0000-31000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Avaria Health & Beauty Corp (251366043)

Revised: 12/2022
Document Id: f0572a47-3c93-34fc-e053-2995a90a2d63
Set id: a3d87ef6-752b-b54b-e053-2a95a90af963
Version: 6
Effective Time: 20221221
 
Avaria Health & Beauty Corp