EMPIRE HAND SANITIZER- alcohol gel

EMPIRE Hand Sanitizer by

Drug Labeling and Warnings

EMPIRE Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by EMPIRE MANAGED SOLUTIONS LLC, Guangzhou Zhongkebaishi Health Industry CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 75% v/v. 

Purpose

Antiseptic

Use

Antiseptic Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

Keep away from heat, flame or sparks.
This product is for external use only.
For use on hands only.
Do not use in or near the eyes. In case of eye contact rinse thoroughly with water.
Do not use on babies less than 2 months of age.
Do not use on open wounds.
Discontinue use if irritation or redness occurs.
If condition persists for more than 72 hours, consult a doctor.

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

Apply product to hands. Rub hands briskly together until dry, ensuring full coverage of all areas of the hands including between the fingers.
Children under 6 should be supervised when using this product.

Other information

Store between 15-30C (59-86F).
Avoid freezing and excessive heat above 40C (104F).
Product may discolor some fabrics or surfaces.

Inactive ingredients

Carbomer, Glycerol, Triethanolamine, Water, Aloe Barbadensis Leaf Extract

Product Labels

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EMPIRE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63708-001
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63708-001-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 63708-001-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 63708-001-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 63708-001-04	437 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 63708-001-05	1893 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
unapproved drug other		03/30/2020

Labeler - EMPIRE MANAGED SOLUTIONS LLC (117334642)

Registrant - EMPIRE MANAGED SOLUTIONS LLC (117334642)