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Dr. Sheffield Anti Itch Cream

Medically reviewed on Aug 8, 2018

Dosage form: cream
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 20mg in 1g, ZINC ACETATE 1mg in 1g
Labeler: Faria LLC dba Sheffield Pharmaceuticals
NDC Code: 11527-069

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts:

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)

DR. SHEFFIELD ANTI ITCH CREAM 
anti itch cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-069
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
ZINC ACETATE (ZINC CATION) ZINC CATION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PEG-20 STEARATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:11527-069-041 TUBE in 1 CARTON
135 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/11/2008
Labeler - Faria LLC dba Sheffield Pharmaceuticals (151177797)
Registrant - Faria LLC dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797manufacture(11527-069)

 
Faria LLC dba Sheffield Pharmaceuticals

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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