Zinc Oxide Paste
FDA Label NDC 69842-468

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Zinc Oxide (NDC 69842-468). 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%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to the 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 ointment 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 between 20⁰ and 25⁰C (68⁰ and 77⁰F)

Inactive Ingredients

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

Other

CVS Health Maximum Strength Diaper Rash Ointment is formulated to help promote healing and protect chafed skin.  It contains 40% zinc oxide and soothing emollients such as lanolin, petrolatum and cod liver oil, a source of vitamins A and D.

CVS Health Diaper Rash Ointment is not manufactured or distributed by Johnson & Johnson Consumer Poducts Company, distributor Desitin.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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Compare to the active ingredient in Desitin

Maximum Strength Diaper Rash Paste

MAXIMUM STRENGTH

Diaper Rash Ointment

ZINC OXIDE 40%

Skin protectant

  • Helps promote healing
  • Protects chafed skin

    • PARBEN - PHTHALATE FREE

    NET WT 4 OZ (113 g)

    Image Description (Mm3)

    Image Description (Mm3)

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