FDA Label for Anti-itch

View Indications, Usage & Precautions

Anti-itch Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Center 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.

Otc - Active Ingredient



Active Ingredients

Diphenhydramine Hydrochloride  2%

Zinc Acetate  0.1%


Otc - Purpose



Purpose

Topical Analgesic

Skin Protectant


Indications & Usage



Uses

For the temporary relief of pain and itching associated with:

  • minor skin irritation
  • allergic itches
  • rashes
  • hives
  • minor burns
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac

Warnings



Warnings


Otc - Do Not Use



Do not use on children under 2 years of age.

For external use only

  • avoid contact with eyes
  • do not apply to open wound or damaged skin.

Otc - Stop Use



Stop use and ask a doctor

  • if condition worsens
  • symptoms persist for 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.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

  • For children under 2 years of age: consult a physician.


Other



Other information

  • Store at 20°C to 25°C (68°F to 77°F).

Inactive Ingredient



Inactive ingredients

Cetyl Alcohol, Diazolidinly urea, Methylparaben, Polyethylene Glycol Monostearate 1000, Propylene Gylcol, Propylparaben, Aloevera extract, Alpha-Tocopherol Acetate, Purified Water.


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

Anti-Itch Cream

NET WT 1 OZ (28 g)


* Please review the disclaimer below.