PHMB DISINFECTANT- polyhexamethylene biguanide spray

PHMB Disinfectant by

Drug Labeling and Warnings

PHMB Disinfectant by is a Otc medication manufactured, distributed, or labeled by Five Hertz (Xiamen) Medical Supplies Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PHMB Disinfectant

Active Ingredient(s)

Polyhexamethylene Biguanide 0.39mg/mL. Purpose: Antiseptic

Purpose

Antiseptic, PHMB Disinfectant

Use

PHMB Disinfectant to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

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 right away.

Directions

• Suitable for the disinfection of human skin and object surface. 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

INGREDIENTS AND APPEARANCE

PHMB DISINFECTANT 
polyhexamethylene biguanide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76579-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF)	POLIHEXANIDE	0.39 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76579-201-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 76579-201-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 76579-201-03	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 76579-201-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 76579-201-05	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 76579-201-06	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 76579-201-07	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 76579-201-08	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2020

Labeler - Five Hertz (Xiamen) Medical Supplies Co., Ltd. (553972905)

Establishment
Name	Address	ID/FEI	Business Operations
Five Hertz (Xiamen) Medical Supplies Co., Ltd.		553972905	manufacture(76579-201)