Zinc Oxide Cream
FDA Label NDC 70050-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Emerging Pharma, Llc for the product Zinc Oxide Cream (NDC 70050-100). 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, stop use and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

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.

Package Label

NDC 70050-100-04 NET WT: 4 oz (113 grams)

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