Label: CORTANE-B- hydrocortisone, pramoxine hcl, chloroxylenol lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51674-0117-2 - Packager: BLANSETT PHARMACAL CO
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 20, 2017
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- DOSAGE AND ADMINISTRATION
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
CORTANE-B
hydrocortisone, pramoxine hcl, chloroxylenol lotionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51674-0117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 mL PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51674-0117-2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/20/2017 Labeler - BLANSETT PHARMACAL CO (037477378) Establishment Name Address ID/FEI Business Operations BLANSETT PHARMACAL CO 037477378 manufacture(51674-0117)
