Zinc Oxide Cream
FDA Label NDC 69367-188

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Westminster Pharmaceuticals, Llc for the product Zinc Oxide (NDC 69367-188). 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 other, active ingredient, purpose, uses, warnings, otc - when using, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Zinc Oxide 22%

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness.

Warnings

For external use only

Otc - When Using

When using this product do not get into eyes

Stop Use And Ask A Doctor If

  • conditions worsen
  • symptoms last more than 7 days or 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

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

Other Information

  • store at 20-30°C (68-86°F)

Inactive Ingredients

aloe barbadensis leaf juice, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E), white petrolatum

Questions?

Call 1-844-221-7294.

Principal Display Panel - 113 Grams Tube Label

Soothing Aloe &
Vitamin E

NDC 69367-188-04

Zinc Oxide 22%

Daily Moisturizing
Diaper Rash Cream

Premium Skin Protectant

  • Helps Heal, Soothe & Prevent Diaper Rash
  • Protects Chafed Skin
  • Gentle on Sensitive Skin

    • NET WT: 4 oz (113 grams)

    Westminster
    Pharmaceuticals

    Principal Display Panel (113 grams Tube Label)

    Principal Display Panel (113 grams Tube Label)

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