Smartowel Wipes by Freshening Paper Products（Hui Zhou）Co.Ltd 84215-003

Smartowel Wipes by

Drug Labeling and Warnings

Smartowel Wipes by is a Otc medication manufactured, distributed, or labeled by Freshening Paper Products（Hui Zhou）Co.Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• in children less than 2 months of age

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

SMARTOWEL WIPES 
wet wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84215-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	0.1 g  in 100

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84215-003-01	40 in 1 BAG; Type 0: Not a Combination Product	04/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/09/2024	12/31/2025

Labeler - Freshening Paper Products（Hui Zhou）Co.Ltd (723246894)

Establishment
Name	Address	ID/FEI	Business Operations
Freshening Paper Products（Hui Zhou）Co.Ltd		723246894	manufacture(84215-003)

Revised: 1/2026

Document Id: 48510ed8-f899-bf8c-e063-6394a90a6964

34390-5

Set id: 15a077c5-f74b-db9c-e063-6394a90a316d

Version: 2

Effective Time: 20260113

 

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