Label: SMILE ANTIBACTERIAL WET WIPES D-PANTHENOL- benzalkonium chloride cloth
-
Contains inactivated NDC Code(s)
NDC Code(s): 81119-002-15, 81119-002-60 - 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:
aqua, glycerin, propylene glycol, tocopheyl acetate, sodium ascorbyl phosphate, retinyl palmitate, panthenol, PEG-40 hydrogenated castro oil, cocamidopropyl betaine, PPG-2-methyl ether, ethylparaben, 2-bromo-2-nitropropane-1,3-doil, centrimonium bromide, citric acid, parfum, limonene, hexyl cinnamal
- Package Labeling:60 pcs
- Package Labeling:15 pcs
-
INGREDIENTS AND APPEARANCE
SMILE ANTIBACTERIAL WET WIPES D-PANTHENOL
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81119-002 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 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) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81119-002-60 60 in 1 PACKAGE 01/01/2021 1 3.736 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:81119-002-15 15 in 1 PACKAGE 01/01/2021 2 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 01/01/2021 Labeler - KPD, Limited Liability Company (681241494)