FDA Label for Western Family Itch Relief

View Indications, Usage & Precautions

Western Family Itch Relief Product Label

The following document was submitted to the FDA by the labeler of this product Western Family Food, Inc.. 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.

Otc - Active Ingredient



Active ingredients                                                                                                     Purpose

Diphenhydramine Hydrochloride 2%..............................................................Topical analgesic

Zinc acetate 0.1%..........................................................................................Skin protectant


Otc - Purpose



Uses temporarily relieves pain and itching associated with:

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak and poison sumac
  • Dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings



Warnings For external use only.


Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



Ask a doctor before use

  • on chicken pox
  • on measles

Otc - When Using



When using this product

  • avoid contact with eyes

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.


Indications & Usage



Directions

  • do not use more than directed
  • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Storage And Handling



Other information

  • store between 20°C and 25°C (68°F and 77°F)

Inactive Ingredient



Inactive ingredients cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, and purified water


Dosage & Administration



Proudly Distributed by:

Western Family Foods, Inc.

P.O. Box 4057

Portland, OR 97208 U.S.A.

Made in Korea


Package Label.Principal Display Panel




* Please review the disclaimer below.