HAND SANITIZER- alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient(s)

Ethanol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• on children less than 2 months of age
• on open skin wounds

WHEN USING

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

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

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 59-86℉ (15-30℃)
• Avoid freezing and excessive heat above 104℉ (40℃)

Inactive ingredients

Water, Olive Oil PEG-7 Esters, Acrylates/C10-30 Alkyl, Acrylate Crosspolymer, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74738-1103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	165.2 mL  in 236 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-7 STEARATE (UNII: VCX261B12R)	4.72 mL  in 236 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	1.18 mL  in 236 mL
WATER (UNII: 059QF0KO0R)	63.956 mL  in 236 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.236 mL  in 236 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.708 mL  in 236 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74738-1103-6	24 in 1 CARTON	04/21/2020
1	NDC: 74738-1103-3	236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/21/2020

Labeler - GuangDong B.C. Biotech Co., Ltd. (403932907)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
GuangDong B.C. Biotech Co., Ltd.		403932907	manufacture(74738-1103) , label(74738-1103)