Label: SUREWELL SANITIZING WIPES- alcohol, glyceryl laurate, sodium levulinate, laurylpyridinium chloride, caprylhydroxamic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 79892-301-01 - Packager: Ifons Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 22, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- direction
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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,
- KEEP OUT OF REACH OF CHILDREN
- INDICATION
- Inactive
- label
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INGREDIENTS AND APPEARANCE
SUREWELL SANITIZING WIPES
alcohol, glyceryl laurate, sodium levulinate, laurylpyridinium chloride, caprylhydroxamic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79892-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 3 g in 100 g GLYCERYL LAURATE (UNII: Y98611C087) (GLYCERYL LAURATE - UNII:Y98611C087) GLYCERYL LAURATE 6 g in 100 g CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) (CAPRYLHYDROXAMIC ACID - UNII:UPY805K99W) CAPRYLHYDROXAMIC ACID 4 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:79892-301-01 90 g in 1 POUCH; Type 0: Not a Combination Product 08/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/22/2020 Labeler - Ifons Corp. (078792164) Registrant - Ifons Corp. (078792164) Establishment Name Address ID/FEI Business Operations ASUNG CO.,LTD 688310506 manufacture(79892-301)