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., QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

For Hand Sanitizing

Warnings

■Keep out of eyes. In case of contact with eyes,
flush thoroughly with water
■Avoid contact with open skin
■Do not inhale or ingest
Stop use and ask a doctor
■If skin iritation or redness develops

Keep out of reach of children.

■Keep out of reach of children. Children under 6
years of age use only under adult supervision
■Not recommended for infants

Directions

■Wet hands thoroughly with product and allow to dry without wiping

Other information

1 Do not store above 105°F
1 May discolor some fabrics

Inactive ingredients

Alcohol, Water (Aqua), Glycerin, Butylene Glycol, Carbomer,
Aminomethyl Propanol, Aloe Barbadensis Leaf Extract

Package Labeling

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50049-001
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50049-001-01	150 in 1 CARTON	04/04/2020
1		45 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50049-001-02	100 in 1 CARTON	04/04/2020
2		75 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 50049-001-03	24 in 1 CARTON	04/04/2020
3		187.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 50049-001-04	20 in 1 CARTON	04/04/2020
4		375 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 50049-001-05	18 in 1 CARTON	04/04/2020
5		750 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 50049-001-06	200 in 1 CARTON	04/04/2020
6		22.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 50049-001-07	150 in 1 CARTON	04/04/2020
7		37.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 50049-001-08	24 in 1 CARTON	04/04/2020
8		112.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 50049-001-09	24 in 1 CARTON	04/04/2020
9		135 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 50049-001-10	24 in 1 CARTON	04/04/2020
10		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 50049-001-11	24 in 1 CARTON	04/04/2020
11		225 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 50049-001-12	24 in 1 CARTON	04/04/2020
12		367.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 50049-001-13	12 in 1 CARTON	04/04/2020
13		900 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 50049-001-14	12 in 1 CARTON	04/04/2020
14		1500 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 50049-001-15	4 in 1 CARTON	04/04/2020
15		2835 mL in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 50049-001-16	4 in 1 CARTON	04/04/2020
16		3750 mL in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 50049-001-17	2 in 1 CARTON	04/04/2020
17		7500 mL in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC: 50049-001-18	1 in 1 CARTON	04/04/2020
18		18750 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	04/04/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
QUANZHOU BESTHOPE HOUSEHOLD PRODUCTS CO.,LTD.		529121531	manufacture(50049-001)