Hand Sanitizer by Xiamen Luwei Industrial Co., Ltd / A03 Lab of BTS HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Xiamen Luwei Industrial Co., Ltd, A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antiseptic hand rub.

Use

Kills 99.9% of most common germs.
Use in the absence of water or towels.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not mix with detergent or other chemicals.

Do not use

Avoid contact with eyes or wound, if product gets into eyes, rinse thoroughly with water.

WHEN USING

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

Use in well ventilated environment.

STOP USE

Stop using this product if skin irritation occurs and consult a doctor immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, seek medical help immediately.

Directions

• Dispense product evenly on palms or on material surface and rub your hands until dry.
• Children should be under adult supervision when using this product.
• No dilute required.

Other information

• Store at room temperature.
• Product may cause discoloration on certain fabrics or materials.

Inactive ingredients

Water, Carbomer, Triethanolamine, Aloe extract, Essence.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76846-1013
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
METHYL BENZOATE (UNII: 6618K1VJ9T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76846-1013-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/08/2020

Labeler - Xiamen Luwei Industrial Co., Ltd (416782594)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Luwei Industrial Co., Ltd		416782594	manufacture(76846-1013) , label(76846-1013)