SMARTOWEL WIPES- wet wipes cloth 
Freshening Paper Products（Hui Zhou）Co.Ltd

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84215-003

Active Ingredient(s)

Chlorhexidine digluconate :0.10%

Benzalkonium chloride:0.10%

Purpose

Antibacterial

Use

Be healthy, wipe before meals!

Warnings

For external use only

Do not use

If irritation occurs during use, please stop using immediately

Stop use and ask a doctor if irritation or rash occurs.

Keep out of reach of children.

Directions

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

No data available

Inactive ingredients

Purified water, Phenoxyethanol, Fragrance, Polysorbate 20, Aloe barbadensis Leaf Juice

Package Label - Principal Display Panel

label

SMARTOWEL WIPES 
wet wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84215-003
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
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84215-003-0140 in 1 BAG; Type 0: Not a Combination Product04/11/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00504/09/2024
Labeler - Freshening Paper Products（Hui Zhou）Co.Ltd (723246894)
Establishment
NameAddressID/FEIBusiness Operations
Freshening Paper Products（Hui Zhou）Co.Ltd723246894manufacture(84215-003)

Revised: 4/2024
Document Id: 15a05193-dc10-67c7-e063-6294a90ac782
Set id: 15a077c5-f74b-db9c-e063-6394a90a316d
Version: 1
Effective Time: 20240409
 
Freshening Paper Products（Hui Zhou）Co.Ltd