Label: OLIVENE DIAPER RASH- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 59886-413-99 - Packager: Fischer Pharmaceuticlas Ltd.
- 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 June 9, 2016
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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- Other Information
- Inactive Ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113 g. Tube Carton
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INGREDIENTS AND APPEARANCE
OLIVENE DIAPER RASH
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59886-413 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 400 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Mineral Oil (UNII: T5L8T28FGP) Petrolatum (UNII: 4T6H12BN9U) Yellow Wax (UNII: 2ZA36H0S2V) Lanolin (UNII: 7EV65EAW6H) Olive Oil (UNII: 6UYK2W1W1E) Oleyl Erucate (UNII: 753W099NQ6) Sorbitan Isostearate (UNII: 01S2G2C1E4) DMDM Hydantoin (UNII: BYR0546TOW) Enoxolone (UNII: P540XA09DR) Propylene Glycol (UNII: 6DC9Q167V3) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Ascorbyl Palmitate (UNII: QN83US2B0N) Glyceryl Monostearate (UNII: 230OU9XXE4) Citric Acid Monohydrate (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59886-413-99 1 in 1 CARTON 01/11/2013 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 01/11/2013 Labeler - Fischer Pharmaceuticlas Ltd. (600158976) Establishment Name Address ID/FEI Business Operations Fischer Pharmaceuticals Ltd. 600410514 MANUFACTURE(59886-413)