Label: ANTI-BACTERIAL WET WIPES- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 78028-004-01, 78028-004-02, 78028-004-03, 78028-004-04, view more78028-004-05, 78028-004-06, 78028-004-07, 78028-004-08, 78028-004-09, 78028-004-10 - Packager: Dalian Daxin Nonwoven Technology Co., Ltd.
- 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 January 14, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- USE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-BACTERIAL WET WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78028-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLY(LAURYLGLUCOSIDE)-7 (UNII: VB00RDE21R) PROPANEDIOL (UNII: 5965N8W85T) BETAINE (UNII: 3SCV180C9W) CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S) CHLORPHENESIN (UNII: I670DAL4SZ) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78028-004-01 50 in 1 PAIL 07/20/2020 1 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product 2 NDC:78028-004-02 70 in 1 PAIL 07/20/2020 2 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product 3 NDC:78028-004-03 80 in 1 PAIL 07/20/2020 3 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product 4 NDC:78028-004-04 100 in 1 PAIL 07/20/2020 4 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product 5 NDC:78028-004-05 30 in 1 BAG 07/20/2020 5 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product 6 NDC:78028-004-06 40 in 1 BAG 07/20/2020 6 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product 7 NDC:78028-004-07 50 in 1 BAG 07/20/2020 7 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product 8 NDC:78028-004-08 60 in 1 BAG 07/20/2020 8 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product 9 NDC:78028-004-09 80 in 1 BAG 07/20/2020 9 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product 10 NDC:78028-004-10 150 in 1 PAIL 07/20/2020 10 6.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/20/2020 Labeler - Dalian Daxin Nonwoven Technology Co., Ltd. (415363991) Establishment Name Address ID/FEI Business Operations Dalian Daxin Nonwoven Technology Co., Ltd. 415363991 manufacture(78028-004)
