Hand Sanitizer

Active Ingredient(s)

Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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 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 and excessive heat above 40C (104F)

Inactive ingredients

Water
Propylene Glycol
Glycerin
Isopropyl Myristate
Tocopheryl Acetate
Carbomer
Aminomethyl Propanol
Fragrance

Package Label - Principal Display Panel

HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75328-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
COSTUS ROOT OIL (UNII: 2WF6750061)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75328-101-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:75328-101-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:75328-101-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:75328-101-04	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:75328-101-05	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC:75328-101-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:75328-101-07	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC:75328-101-08	1890 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC:75328-101-09	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. (542978427)

Name	Address	ID/FEI	Business Operations
Establishment
CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.		542978427	manufacture(75328-101)