Label: BALMA SEPTIC ANTISEPTIC HAND WASH- benzalkonium chloride soap
- NDC Code(s): 59503-6265-2, 59503-6265-6
- Packager: Rochester Midland Corporation
- 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 October 24, 2019
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- Balm Septic Antiseptic Handwash 6265
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INGREDIENTS AND APPEARANCE
BALMA SEPTIC ANTISEPTIC HAND WASH
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59503-6265 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 25.0 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V) DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) PEG-75 LANOLIN (UNII: 09179OX7TB) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59503-6265-2 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/09/2017 2 NDC:59503-6265-6 2500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/09/2017 Labeler - Rochester Midland Corporation (002207041) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(59503-6265)