Label: SMILE ANTIBACTERIAL WET WIPES WITH VITAMINS- benzalkonium chloride cloth
-
Contains inactivated NDC Code(s)
NDC Code(s): 81119-000-15 - Packager: KPD, Limited Liability Company
- 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 December 9, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses
- Warnings
- Directions
- Inactive ingredients:
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
SMILE ANTIBACTERIAL WET WIPES WITH VITAMINS
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81119-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PANTHENOL (UNII: WV9CM0O67Z) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ETHYLPARABEN (UNII: 14255EXE39) BRONOPOL (UNII: 6PU1E16C9W) CETRIMONIUM BROMIDE (UNII: L64N7M9BWR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LIMONENE, (+)- (UNII: GFD7C86Q1W) CITRAL (UNII: T7EU0O9VPP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81119-000-15 15 in 1 PACKAGE 05/01/2020 1 2.28 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 Labeler - KPD, Limited Liability Company (681241494)