Comforte Menstrual Cramp Relief Cream
FDA Label NDC 73603-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pms4pms Llc for the product Comforte Menstrual Cramp Relief Cream (NDC 73603-000). 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 drug facts, active ingredient, purpose, uses, warnings, stop use and ask a doctor if, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with cramps

Warnings

For external use only

Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs.

When Using This Product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucuous membranes
  • do not apply to wounds or damaged skin.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

adults and children over 12 years: 

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin 
  • repeat as necessary, but no more than 4 times daily 
  • children 12 years or younger; ask a doctor

Inactive Ingredients

Shea Butter, Carapa Procera Oil, Sunflower Oil, Lavendar Oil, Calotropis Procera Extract, Sandalwood Oil, Red Cabbage Juice, Turmeric,  Monoglyceride, Diglyceride

Questions?

Call 877.590.6257

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