DISINFECTING WIPES- disinfecting wipes patch 
Bifone (Pinghu) Medical Equipment 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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DISINFENTING WIPES

Active Ingredient(s)

HCLO (Hypochlorou) 0.5% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

scrub the surface of the skin or the surface of the object for sterilization & disinfention and to remove odor.

Warnings

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

Do not use

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

Avoid contact with eyes and mouth.

If allergy occurs,discontinue use and consult with your doctor.

If a child ingests by accident, get medical advice immediately.

Please keep it in a cool and dry place

Other information

Inactive ingredients

water

Package Label - Principal Display Panel

package label

DISINFECTING WIPES 
disinfecting wipes patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:94973-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:94973-002-0160 in 1 BAG11/20/2020
14 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:94973-002-02100 in 1 BAG11/20/2020
24 g in 1 PATCH; Type 0: Not a Combination Product
3NDC:94973-002-03150 in 1 BAG11/20/2020
34 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/20/2020
Labeler - Bifone (Pinghu) Medical Equipment Co., Ltd (554550799)
Establishment
NameAddressID/FEIBusiness Operations
Bifone (Pinghu) Medical Equipment Co., Ltd554550799manufacture(94973-002)

Revised: 11/2020
Document Id: b481cb44-1512-0872-e053-2a95a90ace0b
Set id: b481ced0-bb5a-0831-e053-2a95a90aaf00
Version: 1
Effective Time: 20201119
 
Bifone (Pinghu) Medical Equipment Co., Ltd