Unishield 1% Cream
FDA Label NDC 49314-0005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product Unishield 1% (NDC 49314-0005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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