FDA Label for Unishield 1%

View Indications, Usage & Precautions

Unishield 1% Product Label

The following document was submitted to the FDA by the labeler of this product Unishield. 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 ingredient

Hydrocortisone 1%


Otc - Purpose



Purpose  Anti-itch


Indications & Usage



Uses

  • for temorary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, posison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings



Warnings

For external use only.

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
  • When using this product:

    • Keep out of eyes, ears, and mouth
    • In case of contact with eyes, rinse eyes throughly with water
    • Stop use and ask a doctor if 

      condition worsens or lasts more than 7 days, or clears and occurs again within a few days

      you begin use of other hydrocortisone product unless you have consulted a doctor

      bleeding occurs


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



Directions 

  • For adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Storage And Handling



Other information

  • Store at room temperature (do not freeze)
  • Tamper evident, do not use any opened or torn packets

Inactive Ingredient



Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolactum, phenoxyethanol, water


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