Label: FIRST MARK ULTRA FOAMING ANTIBACTERIAL- benzalkonium chloride solution
- NDC Code(s): 51042-001-10
- Packager: Performance Food Group
- 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 June 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warning
- Directions
- Other information
-
INACTIVE INGREDIENT
Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, polyquaternium 7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/carate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, blue 1
- QUESTIONS
- Principal display panel and representative container
-
INGREDIENTS AND APPEARANCE
FIRST MARK ULTRA FOAMING ANTIBACTERIAL
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51042-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMINE OXIDE (UNII: QWA2IZI6FI) HEXYLENE GLYCOL (UNII: KEH0A3F75J) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK) MYRISTAMINE OXIDE (UNII: J086PM3RRT) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) METHYL GLUCETH-20 (UNII: J3QD0LD11P) GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85) ALCOHOL (UNII: 3K9958V90M) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) POTASSIUM CITRATE (UNII: EE90ONI6FF) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51042-001-10 1250 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/12/2015 Labeler - Performance Food Group (127038714)