Label: LEADER CALAMINE PLUS- zinc oxide lotion lotion
- NDC Code(s): 70000-0400-1
- Packager: Cardinal Health, 110 dba Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 22, 2023
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- WARNINGS
- ACTIVE INGREDIENT
- PURPOSE
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DOSAGE & ADMINISTRATION
Adults and children 2 years of age and older: Shake well before using. CLeanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton of soft cloth, not more than 3 to 4 times daily as needed for comfort.
Children under 2 years of age: Consult a doctor before use.
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER CALAMINE PLUS
zinc oxide lotion lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 80 mg in 1 mL PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYPROMELLOSES (UNII: 3NXW29V3WO) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0400-1 177 mL in 1 CONTAINER; Type 0: Not a Combination Product 02/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 02/15/2019 Labeler - Cardinal Health, 110 dba Leader (063997360)