HAND SANITIZER- alcohol hand sanitizer gel

HAND SANITIZER by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient(s)

Ethyl alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

DO NOT USE

• Do not use on children less than 2 months of age
• Do not use on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth.

If case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs.

Thess may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Children under 6 years of age should be supervised by an adult when using this product.

Other information

Store between 59-86 ℉ (15-30 ℃).

Avoid freezing and excessive heat above 104 ℉ (40 ℃).

Inactive ingredients

Water (Aqua), Acrylates/C10-30 Alkyl/Acrylate Crosspolymer, Triethanolamine, Glycerin, Aloe Extract, Panthenol (pro-Vitamin B5)

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76390-0105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	221.25 mL  in 295 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76390-0105-1	295 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/11/2020

Labeler - Shanghai Soap Co., Ltd. (545258233)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Soap Co., Ltd.		545258233	label(76390-0105) , manufacture(76390-0105)