Terramed Just Think Comfort Herpcare External Analgesic For The Temporary Relief Of Itching And Irritation Ointment
FDA Label NDC 83004-044

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Terramed Just Think Comfort Herpcare External Analgesic For The Temporary Relief Of Itching And Irritation (NDC 83004-044). 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 active ingredients (in each gram)                                                 purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Gram)                                                 Purpose

Menthol 0.1%......................................................................External analgesic

Pramoxine hydrochloride 1%..................................................External analgesic

Uses

temporarily relieves itching and irritation of the external genital area associated with minor skin irritation

Warnings

  • For external use only.

    • Do not use

    • in or around the eyes
    • internally

      • When using this product:

      • use only as directed
      • avoid contact with the eyes and mucous membranes
      • do not apply to open wounds or broken skin

        • Stop use and ask a doctor if:

        • condition worsens
        • symptoms persist for more than 7 days, or clear up and occur again within a few days

          • If pregnant or breast-feeding, ask a health professional before use.

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

Directions

  • adults and children 12 years of age and older:
  • apply to the affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Other Information

  • store at 20°C to 25°C (68°F to 77°F)
  • keep away from direct sunlight and heat
  • keep tightly closed

Inactive Ingredients

alcohol, bee propolis extract, beeswax, calendula officinalis extract, castor oil, colloidal oatmeal, glycerin, lemongrass oil, melissa officinalis (lemon balm) oil, olive extract, olive oil (oxygenated), symphytum officinale (comfrey) extract, willow bark extract.

Product Label

Image Description (Image 44)

Image Description (Image 44)

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