PHMB DISINFECTANT- polyhexamethylene biguanide spray 
Five Hertz (Xiamen) Medical Supplies 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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PHMB Disinfectant

PHMB Disinfectant

Active Ingredient(s)

Polyhexamethylene Biguanide 0.39mg/mL. Purpose: Antiseptic

Purpose

Antiseptic, PHMB Disinfectant

Use

PHMB Disinfectant to kill bacteria and virus that potentially can cause disease, and use when soap and water are not available.

Warnings

For external use only.

Do not use

  • Together with other disinfectants.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly 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 right away.

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 right away.

Directions

  • Suitable for the disinfection of human skin. Shake well before use, and then spray directly on the site to be disinfected - disinfecting time above 3 minutes.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water USP

Package Label - Principal Display Panel

305080100-350

PHMB DISINFECTANT 
polyhexamethylene biguanide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76579-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE0.39 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76579-201-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/17/2023
2NDC:76579-201-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/17/2023
3NDC:76579-201-0380 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/17/2023
4NDC:76579-201-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/17/2023
5NDC:76579-201-05180 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/17/2023
6NDC:76579-201-06200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/17/2023
7NDC:76579-201-07250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/17/2023
8NDC:76579-201-08300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202011/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/30/202011/17/2023
Labeler - Five Hertz (Xiamen) Medical Supplies Co., Ltd. (553972905)
Establishment
NameAddressID/FEIBusiness Operations
Five Hertz (Xiamen) Medical Supplies Co., Ltd.553972905manufacture(76579-201)

Revised: 11/2023
 
Five Hertz (Xiamen) Medical Supplies Co., Ltd.