ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER- polyhexamethylene biguanide gel

Alcohol Free Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Alcohol Free Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ningbo Meilei Electrical Appliance Co.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Polyhexamethylene biguanide 0.09% (w/w)

INACTIVE INGREDIENT

Medical Glycerin，Benzalkonium Chloride，Purified water

PURPOSE

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

WARNINGS

For external use only.Use with caution in people with polxhexammethyl metformin and quaternary ammonium allergies.

DO NOT USE

Do notuse in children less than 2 months of age
Do notuse on open skin wounds
Avoid compatibility with soap and anions, and do not share it with other detergents

STOP USE

When using this product keep out of eyes， ears,and mouth. In case of contact with eyes, rinse eyesthoroughly 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 medical help or contact a Poison Control Center rightaway.

INDICATIONS & USAGE

Antiseptic

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.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Store between 5-40℃(41-104℉)
Avoid freezing and excessive heat above 50℃(122℉)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER 
polyhexamethylene biguanide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82658-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF)	POLIHEXANIDE	9 g  in 10000 g

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82658-002-01	40 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2022
2	NDC: 82658-002-02	50 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2022
3	NDC: 82658-002-03	60 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2022
4	NDC: 82658-002-04	80 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2022
5	NDC: 82658-002-05	100 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2022
6	NDC: 82658-002-06	330 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2022
7	NDC: 82658-002-07	360 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2022
8	NDC: 82658-002-08	400 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/18/2022

Labeler - Ningbo Meilei Electrical Appliance Co.,LTD (540125107)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Meilei Electrical Appliance Co.,LTD		540125107	manufacture(82658-002)