Terramed Just Think Comfort Herpcare Intimate Wash External Analgesic For The Temporary Relief Of Itching And Irritation Liquid
FDA Label NDC 83004-045

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 Intimate Wash External Analgesic For The Temporary Relief Of Itching And Irritation (NDC 83004-045). 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 ml)                                                 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.

Active Ingredients (In Each Ml)                                                 Purpose

Pramoxine hydrochloride 1%                                                      External analgesic

Uses

temporarily relieves itching and irritation of the external genital area.

Warnings

For external use only


Do not use
• internally or inside the vagina
• in or around the eyes

When using this product
• 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
• redness or irritation increases
• 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

  • wash hands before and after applying
  • • adults and children 12 years of age and older: wet the external genital area, apply a small amount, leave on briefly, then rinse thoroughly and pat dry
    • use once or twice daily, or as needed
    • do not use inside the vagina
    • 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

aloe barbadensis leaf juice, caprylyl glycol, citric acid, cocamidopropyl betaine, glycerin, hamamelis virginiana (witch hazel) extract, melaleuca alternifolia (tea tree) leaf oil, panthenol, peg-7 glyceryl cocoate, sodium benzoate, sodium chloride, sodium cocoyl isethionate, water.

Product Label

Image Description (Image 28)

Image Description (Image 28)

* Please review the disclaimer below.