Label: ANTIBACTERIAL WIPES- didecyl dimethyl ammonium chloride, benzalkonium chloride cloth
- 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.
Updated February 3, 2021
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- Active Ingredient(s)
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Storage. Store at room temperature.
- Dispensing. Peel resealable label back slowly. Reseal after use to avoid wipes drying out.
- Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping. To ensure best quality, use within 30 days of opening.
- Disposal. Dispose of used wipes in trash receptacle. Do not flush.
- Inactive ingredients
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
didecyl dimethyl ammonium chloride, benzalkonium chloride cloth
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80202-311 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.008 g in 8.1 g DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE 0.04 g in 8.1 g Inactive Ingredients Ingredient Name Strength AMINO ACIDS, SOY (UNII: NWB9514AZM) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) BRONOPOL (UNII: 6PU1E16C9W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80202-311-40 324 g in 1 BAG; Type 0: Not a Combination Product 02/03/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/03/2021 Labeler - Abby&Finn LLC (107538616)