Dr. Sheffield Diaper Rash Ointment
FDA Label NDC 11527-058

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product Dr. Sheffield Diaper Rash (NDC 11527-058). 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, 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

Other

Drug Facts

Active Ingredient

Zinc Oxide 40%

Purpose

Skin protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

When Using This Product

  • avoid contact with 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, and 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 at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

BHA, Cod liver oil, Fragrance, Lanolin, Petrolatum, Talc, Water

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NDC 11527-058-41

Dr. Sheffield's

Made in the USA

Diaper Rash
Ointment

40% Zinc Oxide Skin Protectant

• Promotes healing

• Relieves chafing

• Paraben free

Helps Treat and
Prevent Diaper Rash

NET WT. 2 oz. (56g)

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Principal Display Panel (Carton Label)

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SHEFFIELD PHARMACEUTICALS www.sheffield-pharmaceuticals.com New London, CT 06320 USA

Questions? 1-800-222-1087 Made in the USA

NDC 11527-058-41

Dr. Sheffield's

Made in the USA

Diaper Rash
Ointment

NET WT. 2 oz. (56g)

40% Zinc Oxide Skin Protectant

Helps Treat and Prevent Diaper Rash

Principal Display Panel (Tube Label)

Principal Display Panel (Tube Label)

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