Label: LEADER DIAPER RASH- zinc oxide ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-637-26 - Packager: CARDINAL HEALTH
- 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 October 11, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER DIAPER RASH
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-637 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.40 g in 1 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) LAVENDER OIL (UNII: ZBP1YXW0H8) PARAFFIN (UNII: I9O0E3H2ZE) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 60 (UNII: CAL22UVI4M) LANOLIN (UNII: 7EV65EAW6H) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SQUALANE (UNII: GW89575KF9) TALC (UNII: 7SEV7J4R1U) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-637-26 1 in 1 CARTON 10/11/2016 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 01/20/2012 Labeler - CARDINAL HEALTH (097537435)