ALCOHOL-BASED DISINFECTANT HAND SANITIZER gel

ALCOHOL-BASED DISINFECTANT HAND SANITIZER by

Drug Labeling and Warnings

ALCOHOL-BASED DISINFECTANT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75%

Purpose

Antimicrobial

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

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

In children less than 2 months of age
On open wounds

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

• When using this product, do not use in
  or near the eyes. In case of contact, rinse
  eyes thoroughly with water. Stop using
  and ask doctor if irritation or rash appears
  and lasts. Keep out of reach of children.
  If swollowed, get medical help or contact a
  Poison Control Center immediately.

Other information

• Other Information:
  Store below 106° F (41° C)
  May discolor certain fabrics or surfaces.

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

USE

Place enough Product in your palm to thoroughly spread on both hands and rubinto the skin until dry.
Children under 6 years of age should be supervised when using this product see full prescribing information for label

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ALCOHOL-BASED DISINFECTANT HAND SANITIZER 
alcohol-based disinfectant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74757-002
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
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74757-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 74757-002-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 74757-002-02	330 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 74757-002-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 74757-002-05	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 74757-002-06	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 74757-002-07	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 74757-002-08	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC: 74757-002-09	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC: 74757-002-10	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC: 74757-002-11	3000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
12	NDC: 74757-002-12	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
13	NDC: 74757-002-13	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/20/2020

Labeler - GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD (540725476)

Registrant - GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD (540725476)

Establishment
Name	Address	ID/FEI	Business Operations
GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD		540725476	manufacture(74757-002)