Label: AIRE-MASTER FOAMING AB TRICLOSAN FREE- benzalkonium chloride liquid
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NDC Code(s):
65133-190-01,
65133-190-02,
65133-190-03,
65133-190-04, view more65133-190-05, 65133-190-06, 65133-190-07, 65133-190-08, 65133-190-09, 65133-190-10, 65133-190-11, 65133-190-12, 65133-190-13, 65133-190-14, 65133-190-15, 65133-190-16
- Packager: Aire-Master of America, Inc.
- 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 July 27, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AIRE-MASTER FOAMING AB TRICLOSAN FREE
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65133-190 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 10 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCO GLUCOSIDE (UNII: ICS790225B) LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65133-190-09 4 in 1 PACKAGE 01/01/2016 07/20/2022 1 NDC:65133-190-01 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:65133-190-02 208198 mL in 1 DRUM; Type 0: Not a Combination Product 01/01/2016 12/31/2024 3 NDC:65133-190-03 946353 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2016 07/20/2022 4 NDC:65133-190-10 24 in 1 PACKAGE 01/01/2016 07/20/2022 4 NDC:65133-190-04 236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:65133-190-12 6 in 1 PACKAGE 01/01/2016 07/20/2022 5 NDC:65133-190-11 12 in 1 PACKAGE 5 NDC:65133-190-05 532.3 mL in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:65133-190-13 8 in 1 PACKAGE 01/01/2016 07/20/2022 6 NDC:65133-190-06 1000 mL in 1 POUCH; Type 0: Not a Combination Product 7 NDC:65133-190-15 48 in 1 PACKAGE 01/01/2016 07/20/2022 7 NDC:65133-190-14 24 in 1 PACKAGE 7 NDC:65133-190-07 50.2 mL in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:65133-190-16 4 in 1 PACKAGE 01/01/2016 07/20/2022 8 NDC:65133-190-08 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2016 05/31/2025 Labeler - Aire-Master of America, Inc. (057897381) Establishment Name Address ID/FEI Business Operations Aire-Master of America, Inc. 057897381 manufacture(65133-190)