Maximum Strength Diaper Rash
FDA Label NDC 0363-9160

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Maximum Strength Diaper Rash (NDC 0363-9160). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide, 40.0%

Purpose

Skin protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only.

When Using This Product

  • do not get into eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other Information

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

cod liver oil, talc, petrolatum, lanolin, water, methylparaben, fragrance, BHA

Questions Or Comments?

1-800-925-4733

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Well at Walgreens Zinc Oxide Ointment

Skin Protectant

  • For external use only
  • Avoid contact with eyes

    • NET WT 2 OZ (57 g)

    Walgreens Pharmacist Recommended‡

    ‡Walgreens Pharmacist Survey Study, November 2012.

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