Corticol-aloe
FDA Label NDC 53145-430

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Corticol-aloe (NDC 53145-430). 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, inactive ingredient, otc - questions, 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

  • temproarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewlery
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves extranal anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

Warnings

For external use only.

Do not use

  • in the genital area if you have a vaginal discharg. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor

    • When using this product

    • avoid contact with the eyes
    • do not use more than directed unless told to do so by a doctor
    • do not put directly into the rectum by using fingers or any mechanical device or applicator

      • Stop use and ask a doctor if

      • condition worsen, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
      • rectal 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 itchin of skin irritiation, inflammation and rashes:
  • adults and children 2 years of agea and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • for external anal and genital itching, adults
  • when practical, clean the affected area with mild soap and warm water and rinse thouroghly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor   

Inactive Ingredient

Inactive ingredients

aloe barbadensis leaf juice, beeswax, clacium acetate, cetearyl alcohol, glycerin, maltodextrin, mehtylparaben, mineral oil, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water, white petrolatum

Otc - Questions

Questions

www.menperdistributors.com or 1-800-560-5223 M-F 9 am - 4 pm EST

Package Label.Principal Display Panel

Corticol (Corticol)

Corticol (Corticol)

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