HAND SANITIZER- ethyl alcohol gel

hand sanitizer by

Drug Labeling and Warnings

hand sanitizer by is a Otc medication manufactured, distributed, or labeled by QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Use

■ Hand sanitizer to help decrease bacteria on
the skin
■When water, soap & towel are not
available.
■Recommended for repeated use,

WARNINGS

For external use only■ Flammable
Keep away from fire or flame
Do not apply around eyes. Do not use in ears & mouth.
When using this product. avoid contact with eyes.
In case of contact flush eyes with water
Stop use and ask a doctor it redness or irritation
develop and persist for more than 72 hours

keep out of reach of children

Keep out of reach of children. Children must be
supervised in use of this product

Directions

Pump as needed into your palms and thoroughly
spread on both hands. Rub into skin until dry
Other Information Store at 20C(88" to 77"F)
may discolor fabrices

Inactive ingredients

Aloohol, Water(Aqua), Glycenin, Butylene Glycol, Carbomer,Aminomethyl Propanol, Aloe Barbadensis Leaf Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50049-100
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
CARBOMER 934 (UNII: Z135WT9208)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50049-100-01	100 in 1 CARTON	03/21/2020
1		45 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50049-100-02	60 in 1 CARTON	03/21/2020
2		75 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 50049-100-03	24 in 1 CARTON	03/21/2020
3		187.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 50049-100-04	12 in 1 CARTON	03/21/2020
4		375 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 50049-100-05	6 in 1 CARTON	03/21/2020
5		750 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 50049-100-06	4 in 1 CARTON	03/21/2020
6		2835 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 50049-100-07	4 in 1 CARTON	03/21/2020
7		3500 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 50049-100-08	24 in 1 CARTON	03/21/2020
8		112.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 50049-100-09	24 in 1 CARTON	03/21/2020
9		135 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 50049-100-10	24 in 1 CARTON	03/21/2020
10		150 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	part333E	03/21/2020

Labeler - QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD. (529121531)

Establishment
Name	Address	ID/FEI	Business Operations
QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.		529121531	manufacture(50049-100)