SUREWELL SANITIZING WIPES- alcohol, glyceryl laurate, sodium levulinate, laurylpyridinium chloride, caprylhydroxamic acid liquid 
Ifons Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

ALCOHOL, GLYCERYL LAURATE, SODIUM LEVULINATE, LAURYLPYRIDINIUM CHLORIDE, CAPRYLHYDROXAMIC ACID

PURPOSE

ANTIMICROBIAL

direction

Open cover, pull needed number of sheets, reseal after each use.

Do not use

Do not use: Do not apply it on skin where you have eczema, wounded, irritated.

storage and cautions for handling
A) Avoid storing under direct sunlight, hot and cool place.
B) keep the sticker or stopper closed after use.
C) Do not throw in the flush toilet it. because it may be clogged if it is thrown away in the flush toilet
D) If wet tissue put back into the package with contaminated hands, it may be deteriorated.
recommended to use within 1 month of opening.

Stop use and ask a doctor,

If anyone of following symptoms such as red spot, swollenness and/or itching, occurs when using cosmetics, or symptoms appear by direct sunlight. stop using it and consult a doctor immediately.

Keep out of reach of children

INDICATION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

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

Inactive

Water, Methylpropanediol, Sodium coco pg-dimonium chloride phosphate, Levulinic acid

label

79892-301-01

79892-301-01

SUREWELL SANITIZING WIPES 
alcohol, glyceryl laurate, sodium levulinate, laurylpyridinium chloride, caprylhydroxamic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79892-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3 g  in 100 g
GLYCERYL LAURATE (UNII: Y98611C087) (GLYCERYL LAURATE - UNII:Y98611C087) GLYCERYL LAURATE6 g  in 100 g
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) (CAPRYLHYDROXAMIC ACID - UNII:UPY805K99W) CAPRYLHYDROXAMIC ACID4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL) 5 g  in 100 g
SODIUM LEVULINATE (UNII: VK44E1MQU8) 5 g  in 100 g
COCOTRIMONIUM CHLORIDE (UNII: KB94658IHQ)  
LEVULINIC ACID (UNII: RYX5QG61EI)  
WATER (UNII: 059QF0KO0R)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79892-301-0190 g in 1 POUCH; Type 0: Not a Combination Product08/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/22/2020
Labeler - Ifons Corp. (078792164)
Registrant - Ifons Corp. (078792164)
Establishment
NameAddressID/FEIBusiness Operations
ASUNG CO.,LTD688310506manufacture(79892-301)

Revised: 8/2020
Document Id: ad72de17-b6dd-51c8-e053-2a95a90ac5fb
Set id: ad72de17-b6dc-51c8-e053-2a95a90ac5fb
Version: 1
Effective Time: 20200822
 
Ifons Corp.