Label: CALAMINE CLEAR- pramoxine hydrochloride and zinc acetate lotion lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70000-0397-1 - Packager: Cardinal Health, 110 dba Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 16, 2022
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- ACTIVE INGREDIENT
- PURPOSE
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- WARNINGS
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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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)