Label: PREMIUM PROTECTION ANTIBACTERIAL HAND- benzalkonium chloride liquid
- NDC Code(s): 77617-002-01, 77617-002-02
- Packager: Maintex
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 22, 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
- Warnings
- When Using this Product
- Keep out of reach of children.
- Directions
- Inactive Ingredients
- Premium Protection Antibacterial Hand Soap
-
INGREDIENTS AND APPEARANCE
PREMIUM PROTECTION ANTIBACTERIAL HAND
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77617-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 13 kg in 100 kg Inactive Ingredients Ingredient Name Strength ALOE VERA FLOWER (UNII: 575DY8C1ER) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) MAGNESIUM NITRATE (UNII: 77CBG3UN78) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) FD&C RED NO. 40 (UNII: WZB9127XOA) EDETATE SODIUM (UNII: MP1J8420LU) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77617-002-02 4 in 1 BOX 04/15/2018 1 NDC:77617-002-01 3.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/15/2018 Labeler - Maintex (008317307) Registrant - Maintex (008317307) Establishment Name Address ID/FEI Business Operations Morgan Gallacher Inc DBA Custom Chemical Formulators Inc 028311595 manufacture(77617-002) , api manufacture(77617-002) , pack(77617-002)