Label: LEADER ZINC OXIDE- zinc oxide ointment
- NDC Code(s): 70000-0334-1
- Packager: Cardinal Health 110,Inc.
- 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.
Updated January 6, 2022
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- Drug Facts
For external use only
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days to clear up and occur again within a few days
- apply liberally as often as necessary
For Diaper Rash
- change wet or soiled diapers promptly
- cleanse the diaper area and allow to dry
- apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged
For Poison Ivy, poison oak and poison sumac;
- cleanse the affect area and pat dry
- apply ointment liberally, as often as necessary, using a cotton ball, sterile swab or gauze
- wash hands after use.
- Inactive ingredients
- Questions or comments?
- Principal Display Panel – Jar Label
INGREDIENTS AND APPEARANCE
LEADER ZINC OXIDE
zinc oxide ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0334 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0334-1 454 g in 1 JAR; Type 0: Not a Combination Product 03/29/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/29/2019 Labeler - Cardinal Health 110,Inc. (063997360)