INSTANT HAND SANITIZER- alcohol hand sanitizer gel

INSTANT HAND SANITIZER by

Drug Labeling and Warnings

INSTANT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Shanghai Chuangshi Industry Group Co., Ltd, A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable.

Keep away from heat or flame.

For external use only.

Do not use

When using this product, do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

WHEN USING

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash appears or lasts.

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

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 86℉ (30℃).
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Glycerin, Carbomer, Fragrance.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-239
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	375 mL  in 500 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: 73557-239-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020

INSTANT HAND SANITIZER 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-233
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: 73557-233-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020

INSTANT HAND SANITIZER 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-231
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: 73557-231-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020

Labeler - Shanghai Chuangshi Industry Group Co., Ltd (546872672)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Industry Group Co., Ltd		546872672	manufacture(73557-231, 73557-233, 73557-239) , label(73557-231, 73557-233) , relabel(73557-239)