Empire hand sanitizer by EMPIRE MANAGED SOLUTIONS LLC

Drug Details [pdf]

EMPIRE HAND SANITIZER- alcohol gel
EMPIRE MANAGED SOLUTIONS LLC

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Drug Facts

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

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

Warnings

FLAMMABLE.
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. If swallowed, seek medical advice or contact a Poison Control Center right away.

Direction

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.

Inactive ingredient

Glycerin, Water, Aloe, CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED), Trolamine

Other information

Store between 15-30C (59-86F).

Product label

image description

EMPIRE HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63708-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63708-002-01	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2021	07/31/2023
2	NDC: 63708-002-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2021	07/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	09/04/2021	07/31/2023

Labeler - EMPIRE MANAGED SOLUTIONS LLC (117334642)

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Daieme Cosmetic Co,.Ltd		542359812	manufacture(63708-002)

Revised: 10/2023

Document Id: 08f52343-b283-3c16-e063-6294a90af9b3

Set id: 67c5e0f0-9bb1-4bf2-8c52-5f9394dfdf45

Version: 2

Effective Time: 20231030