Dr. Sheffield Anti Itch Cream
FDA Label NDC 11527-069

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 Anti Itch Cream (NDC 11527-069). 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 ingredients, purpose, uses, warnings, keep this and all drugs out of the reach of children., directions, inactive ingredients, principal display panel 1.25 oz carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

For temporary relief from pain and itching associated with :

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • rashes due to poison ivy, poison oak, and poison sumac

    • Dries the oozing and weeping of poison

    • ivy
    • oak
    • sumac

Warnings

For external use only

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine , even one taken by the mouth.

    • Ask a Doctor before use

    • on chicken pox
    • on measles

      • When using this product avoid contact with eyes.

      Stop use and ask a doctor if

      • conditions worsen or does not improve within 7 days
      • symptoms persist for more than 7 days or clear up and occur agian within a few days

Keep This And All Drugs Out Of The Reach Of Children.

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

  • do not use more than directed
  • adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily
  • children under 2 years of age , consult a doctor

    • Other Information

    • Store at controlled room temperature 20°-25°C (68° - 77°F)
    • Close the cap tightly after use

Inactive Ingredients

Cetyl Alcohol, Diazolldinyl Urea, Methylparaben, PEG 20 Sterate, Proplylene Glycol, Proplyparaben, Purified Water

Principal Display Panel 1.25 Oz Carton

Dr. Sheffield                               NDC 11527-069-04

SHEAF-FIELD trade mark

ANTI -ITCH cream

Topical analgesic & Skin Protectant

Made in the USA                       NET WT. 1.25 oz ( 35g)

Principal Display Panel 1.25 Oz Tube

Sheffield Pharmaceuticals  www.sheffield-pharmaceuticals.com, New London, CT 06320 USA

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

Dr. Sheffield's                                             NDC 11527-069-04

SHEAF-FIELD TM       2% Diphenhydramine Hydrochloride and 0.1% Zinc Acetate

ANTI-ITCH cream           Histamine blocker releieves itching from insect bites & skin irritations

Topical Analgesic & Skin Protectant                  NET WT. 1.25oz ( 35g)

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