HAND SANITIZER- alcohol solution

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Taizhou Duorui Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help decrease 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 or 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

Keep out of reach of children. If swallowed, get immediate 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 15-30C (59-86F)

Avoid freezing or excessive heat above 40C (104F)

Inactive ingredients

Glycerin, Triethanolamine, Carbomer 940, Aloe Vera Leaf, Alpha Tocopherol, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80800-001
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
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80800-001-01	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
2	NDC: 80800-001-02	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
3	NDC: 80800-001-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
4	NDC: 80800-001-04	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
5	NDC: 80800-001-05	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
6	NDC: 80800-001-06	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
7	NDC: 80800-001-07	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
8	NDC: 80800-001-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
9	NDC: 80800-001-09	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
10	NDC: 80800-001-10	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
11	NDC: 80800-001-11	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
12	NDC: 80800-001-12	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
13	NDC: 80800-001-13	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020
14	NDC: 80800-001-14	53 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/09/2020

Labeler - Taizhou Duorui Biotechnology Co., Ltd. (713362289)

Establishment
Name	Address	ID/FEI	Business Operations
Taizhou Duorui Biotechnology Co., Ltd.		713362289	manufacture(80800-001)