SUNBEAM WASH-FREE HAND SANITIZER/DISINFECTANT gel

Sunbeam Wash-Free Hand Sanitizer/Disinfectant by

Drug Labeling and Warnings

Sunbeam Wash-Free Hand Sanitizer/Disinfectant by is a Otc medication manufactured, distributed, or labeled by Xiamen Sunbeam Industries Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Compound quaternary ammonium salt, Alcohol 60%v/v

Purpose

Antibacterial &Disinfectant

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

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

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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. If swallowed, get medical help or contact a Poison Control Center right away.

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

If swallowed, get med-ical 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

Storage sealed, stored in ventilated and dry place at normal temperature.

Avoiding freezing and excessive heat above 40C(104F)

Inactive ingredients

vitamin E, aloe extract, flavor, carbomer, purified water, USP

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SUNBEAM WASH-FREE HAND SANITIZER/DISINFECTANT 
sunbeam wash-free hand sanitizer/disinfectant gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78214-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE (UNII: V5VD430YW9)
METHYL SALICYLATE (UNII: LAV5U5022Y)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78214-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
2	NDC: 78214-001-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
3	NDC: 78214-001-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
4	NDC: 78214-001-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
5	NDC: 78214-001-05	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
6	NDC: 78214-001-06	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
7	NDC: 78214-001-07	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
8	NDC: 78214-001-08	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
9	NDC: 78214-001-09	3000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
10	NDC: 78214-001-10	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
11	NDC: 78214-001-11	100000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
12	NDC: 78214-001-12	150000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020
13	NDC: 78214-001-13	220000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/19/2020

Labeler - Xiamen Sunbeam Industries Ltd. (529394725)

Registrant - Xiamen Sunbeam Industries Ltd. (529394725)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Sunbeam Industries Ltd.		529394725	manufacture(78214-001)