Antibacterial Hand Sanitizer

Antibacterial Hand Sanitizer

Drug Labeling and Warnings

Drug Details

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ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel 
Zhejiang Ayan Biotech Co.,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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Antibacterial Hand Sanitizer

Drug Facts

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses:

For Hand Sanitizing

Warnings:

For external use only - hands


Flammable. Keep away from heat and flame.

When using this product,

keep out of eyes. In case of contact with eyes, flush thoroughly with water.
Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor

if skin irritation develops.

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.

Directions:

Wet hands thoroughly with product and allow to dry without wiping.
For children under 6 age use only under adult supervision.
Not recommended for infants.

Other Information:

Do not store above 105°F.

May discolor some fabrics.

Inactive Ingredients

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate,
Triethanolamine, Water.

Package Labeling:

Label

ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70412-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70412-112-361 in 1 BOX01/18/2016
1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/18/2016
Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)

Revised: 3/2020
 
Zhejiang Ayan Biotech Co.,Ltd.


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