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  5. Label Information: Dr. Sheffield Anti Itch Cream

FDA Label for Dr. Sheffield Anti Itch Cream

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. PRINCIPAL DISPLAY PANEL 1.25 OZ CARTON
    9. PRINCIPAL DISPLAY PANEL 1.25 OZ TUBE

Dr. Sheffield Anti Itch Cream Product Label

The following document was submitted to the FDA by the labeler of this product Sheffield Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


* Please review the disclaimer below.