FDA Label for Anti-itch Extra Strength

View Indications, Usage & Precautions

Anti-itch Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Personal Care Products, 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.

Active Ingredients



Drug Facts

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%


Purpose



Topical analgesic

Skin protectant


Keep Out Of Reach Of Children



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


Uses



For the temporary relief from pain and itching associated with:

  • insect bites
  • sunburn
  • minor skin irritations
  • minor burns
  • scrapes

  • Dries the oozing and weeping of

    • poison ivy
    • poison oak
    • poison 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 mouth

  • Ask a doctor before use

    • on chicken pox
    • on measles

    • When using this product avoid contact with the eyes

      Stop use and ask a doctor if

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

Directions



  • do not use more than directed
  • adults and children 2 years of age and older, apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • use daily for 4 weeks

Other Information



  • store at temperature between 58° - 77° F  (15° - 30° C)
  • do not use if seal on tube is punctured or missing

Inactive Ingredients



cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene gylcol, propylparaben, purified water


Product Label



DRUGSTORE-Rx

SMART WELLNESS

Extra Strength

Anti-Itch Cream


Topical Analgesic and Skin Protectant


Histamine Blocker

Relieves itching from

    * Poison ivy
    * Poison sumac
    * Sunburn
    * Insect bites


NET WT. 1.25 OZ.  (35 g)

DRUGSTORE-Rx

SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item. That's smart wellness!

Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 48084 U.S.A.

Code No. MH/DRUGS/KD-313               Made in India



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