Label: DR SMITHS DIAPER- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 71269-006-03 - Packager: MainPointe Pharmaceuticals, LLC
- 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 February 24, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- Storage and Handling
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR SMITHS DIAPER
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71269-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) OLIVE OIL (UNII: 6UYK2W1W1E) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) THYMOL IODIDE (UNII: A51HJM3XSU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71269-006-03 85 g in 1 TUBE; Type 0: Not a Combination Product 01/19/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/19/2018 Labeler - MainPointe Pharmaceuticals, LLC (080544378) Registrant - Mission Pharmacal (927726893)