Label: CALADRYL- ferric oxide red, zinc oxide, and pramoxine hydrochloride lotion
- NDC Code(s): 0187-5465-06
- Packager: Bausch Health US, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 17, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions/Comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
CALADRYL
ferric oxide red, zinc oxide, and pramoxine hydrochloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0187-5465 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 1.36 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 78.65 mg in 1 mL PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0187-5465-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/16/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M014 08/16/2013 Labeler - Bausch Health US, LLC (831922468) Establishment Name Address ID/FEI Business Operations Trillium Health Care Products Inc. 255426306 manufacture(0187-5465)