HBA ANTI BACTERIAL LIQUID- polihexanide spray 
Henan Huibo Medical 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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POLIHEXANIDE Spray

Active Ingredient

Polyhexamethylene biguanide 0.2% w/w

Purpose

Antibacterial

Use

■ Skin disinfection

WARNINGS

For external use only

Do not use if you are allergic to any ingredients listed

Discontinue use if irritation or redness occur. Consult a doctor if condition lasts for more than 72 hours

Do not get into eyes. Rinse thoroughly with water if contact occurs

keep out of reach of children

Keep out of reach of children. If swallowed, see a doctor or contact a poison control center immediately

Directions

Spray the product directly on the skin, no need to wash

Immerse a piece of gauze in the disinfectant, then wipe the site of action repeatedly or do wet compress

When disinfect the objects which have direct contact with skin, just spray the product directly

Inactive ingredients

Water, Glycerol

image description

HBA ANTI BACTERIAL LIQUID 
polihexanide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79158-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE0.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCEROL FORMAL (UNII: 3L7GR2604E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79158-003-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/22/2020
Labeler - Henan Huibo Medical Co., Ltd. (560455084)
Establishment
NameAddressID/FEIBusiness Operations
Henan Huibo Medical Co., Ltd.560455084manufacture(79158-003)

Revised: 7/2020
Document Id: ab0dcc04-ef6b-8331-e053-2a95a90a2ee8
Set id: 6cc9a531-4e8e-453c-80c8-c71b1bc8dff6
Version: 1
Effective Time: 20200722
 
Henan Huibo Medical Co., Ltd.