FDA Label for Leader Zinc Oxide

View Indications, Usage & Precautions

Leader Zinc Oxide Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110,inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active Ingredient

Zinc oxide 20%


Purpose



Skin Protectant


Uses



  • helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings



For external use only


Otc - When Using



When using this product, avoid contact with the eyes


Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.


Directions



  • 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



mineral oil, petrolatum


Questions Or Comments?



Call 1-800-222-1087

Store at room temperature 20 - 25°C (68° - 77°F).


Principal Display Panel – Jar Label



Leader®       NDC 70000-0334-1

Zinc Oxide

Ointment USP•

Multi Purpose Skin Protectant 

provides soothing relief from poison ivy,

oak and sumac

Treats and prevents diaper rash

Net Wt 1 lb (454 g)



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