Zinc Oxide Ointment
FDA Label NDC 69771-109

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-gentle Corporation for the product Zinc Oxide (NDC 69771-109). 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, when using this product, stop use and ask a doctor if, do not use on, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Active Ingredient

Zinc Oxide (20%w/w)

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • dries the oozing and weeping of:
    • poison ivy
    • poison oak
    • poison sumac

Warnings

For external use only

When Using This Product

  • do not get into eyes
  • do not use over large area of the body

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days
  • if you are allergic to any of these ingredients

Do Not Use On

  • deep puncture wounds
  • animal bites
  • serious burns

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 For Diaper Rash

  • change wet and soiled diaper promptly
  • cleanse the diaper area and allow to dry
  • apply as needed

Other Information

  • store at 59°-86°F (15°-30°C)
  • avoid excessive heat

Inactive Ingredients

Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin

Principal Display Panel - 28.4 G Tube Box

GeriGentle

Zinc Oxide Ointment
SKIN PROTECTANT • 1 oz

Net Wt. 1oz. (28.4g)

Reorder No.
16-720

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