ZAPPY ULTIMATE ANTISEPTIC WIPES- wet wipes cloth 
Freshening Paper Products(Hui Zhou)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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84215-001

Active Ingredient(s)

Chlorhexidine digluconate :0.100%

Benzalkonium chloride:0.100%

Purpose

Anti corrosion and antibacterial, wiping and disinfecting

Use

Skin irritation is not common, but if a reaction occurs, please stop using immediately.

Discard used wipe in trash.

Do not flush in toilet.

SAFE & NO RINSING .REQUIRED.

Warnings

●Avoid contact with eyes.

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.

Directions

Instruction for Use: Ready to use wipes. Wipe all areas of hands or surface tll visibly clean and air dry. Use a new wipe for a new surface.

Other information

Nothing

Inactive ingredients

Purified water, Phenoxyethanol, Sodium gluconate, Fragrance, Benzalkonium chloride (0.10%W/v), Chlorhexidine digluconate (0.10%W/v), Polyaminopropyl biguanide, Ethylhexylglycerin, Polysorbate 20, Tocopheryl acetate

Package Label - Principal Display Panel

1

ZAPPY ULTIMATE ANTISEPTIC WIPES 
wet wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84215-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.1 g  in 100 
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84215-001-0150 in 1 BAG; Type 0: Not a Combination Product04/10/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/08/2024
Labeler - Freshening Paper Products(Hui Zhou)Co.Ltd (723246894)
Establishment
NameAddressID/FEIBusiness Operations
Freshening Paper Products(Hui Zhou)Co.Ltd723246894manufacture(84215-001)

Revised: 4/2024
Document Id: 15937afb-8310-6f15-e063-6394a90a9efe
Set id: 15936ef7-2b20-e7a1-e063-6294a90a63ed
Version: 1
Effective Time: 20240408
 
Freshening Paper Products(Hui Zhou)Co.Ltd