ANTIBACTERIAL HAND SANITIZER- alcohol gel

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ayan Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

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.

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

Carborner, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water. Blue 1 (CI 42090), Red 33 (CI 17200)

Package Labeling: 70412-135-15

Package Labeling: 70412-135-30

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-135-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2020
2	NDC: 70412-135-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/17/2020

Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co.,Ltd.		544377996	manufacture(70412-135)