DISINFECTING WET WIPE- polyhexamethylene biguanide cloth 
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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Disinfecting Wet Wipe

Disinfecting Wet Wipe

Active Ingredient(s)

Polyhexamethylene Biguanide 0.9mg/cloth. Purpose: Antiseptic

Purpose

Antiseptic, Disinfecting Wet Wipe

Use

Disinfecting Wet Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not use

  • in children less than 2 months of age

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

  • Take out the wet wipes and wipe directly. Disinfecting time on hand no more than 1 min; Disinfecting time on whole skin and mucosa no more than 5 min.
  • 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

15080120

DISINFECTING WET WIPE 
polyhexamethylene biguanide cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76579-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE0.9 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76579-301-011 in 1 PACKAGE; Type 0: Not a Combination Product03/30/202011/17/2023
2NDC:76579-301-0250 in 1 PACKAGE; Type 0: Not a Combination Product03/30/202011/17/2023
3NDC:76579-301-0380 in 1 PACKAGE; Type 0: Not a Combination Product03/30/202011/17/2023
4NDC:76579-301-04120 in 1 PACKAGE; 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(76579-301)

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