ANTIBACTERIAL HAND SANITIZER- alcohol hand sanitizer gel

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Accompany USA I Inc, A03 Lab of BTS, Shanghai Chuangshi Industry Group Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antibacterial

Use

For handwashing to decrease bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

Do not use

For external use only.

WHEN USING

When using this product avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash develops and continues for 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep Out of reach of children.

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

Directions

• Take a palmful (5grams) of product in one hand.
• Spread on both hands and rub into skin until dry (approximately 1 to 2 minutes).

Other information

• Do not store above 86℉ (30℃)
• May discolor some fabrics
• Harmful to wood finishes and plastics

Inactive ingredients

Water, Glycerin, Carbomer, Fragrance.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76816-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	45 mL  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CLOVE (UNII: K48IKT5321)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76816-101-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/30/2020

ANTIBACTERIAL HAND SANITIZER 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76816-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CLOVE (UNII: K48IKT5321)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76816-102-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/30/2020

Labeler - Accompany USA I Inc (076052578)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Accompany USA I Inc		076052578	label(76816-101, 76816-102)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Industry Group Co., Ltd		546872672	manufacture(76816-101, 76816-102)