NDC | 70000-0397-1 |
Set ID | 7f733c0a-82b2-d3b0-e053-2991aa0a6b0f |
Category | HUMAN OTC DRUG LABEL |
Packager | Cardinal Health, 110 dba Leader |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALAMINE CLEAR
pramoxine hydrochloride and zinc acetate lotion lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0397 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CAMPHOR (NATURAL) (UNII: N20HL7Q941) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0397-1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/15/2019 Labeler - Cardinal Health, 110 dba Leader (063997360)