Zinc Oxide Ointment
FDA Label NDC 11822-0534

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Zinc Oxide (NDC 11822-0534). 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

*This product not manufactured or disturbed by Johnson & Johnson Consumer Products Company, distributor of Desitin Rapid Relief Zinc Oxide Diaper Rash Cream.

DISTRIBUTED BY:

RITE AID 

30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARENTEE

if you're not satisfied, we'll happily refund your money. 

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PARABEN FREE

PHTHALATE FREE

Compare to the ingredients in Destin Maximum Strength Original Rash Paste

MAXIMUM STRENGTH

DIAPER RASH PASTE

40% ZINC OXIDE

Specially formulated for effective diaper rash care in rich, thick formula

Helps heal, soothe & prevent diaper rash

Dye free

MAXIUMUM STRENGTH ZINC OXIDE DIAPER RASH OINTMENT AVAILABLE

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