ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER- polyhexamethylene biguanide gel 
Ningbo Meilei Electrical Appliance Co.,LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Polyhexamethylene biguanide 0.09% (w/w)

Medical Glycerin,Benzalkonium Chloride,Purified water

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

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

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

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. If swallowed, get medical help or contact a Poison Control Center rightaway.

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.

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.

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

40ML50ML60ML

80ML100ML330ML360ML400ML

ALCOHOL FREE ANTIBACTERIAL HAND SANITIZER 
polyhexamethylene biguanide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82658-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE9 g  in 10000 g
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82658-002-0140 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
2NDC:82658-002-0250 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
3NDC:82658-002-0360 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
4NDC:82658-002-0480 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
5NDC:82658-002-05100 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
6NDC:82658-002-06330 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
7NDC:82658-002-07360 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
8NDC:82658-002-08400 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/18/2022
Labeler - Ningbo Meilei Electrical Appliance Co.,LTD (540125107)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Meilei Electrical Appliance Co.,LTD540125107manufacture(82658-002)

Revised: 3/2022
Document Id: d9af8a69-6422-808c-e053-2a95a90a521c
Set id: d9af8a69-6421-808c-e053-2a95a90a521c
Version: 1
Effective Time: 20220308
 
Ningbo Meilei Electrical Appliance Co.,LTD