Menthol Cream
FDA Label NDC 62212-252

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amish Origins Llc for the product Menthol (NDC 62212-252). 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 ingredient, purpose, uses:, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 8%

Purpose

Topical Analgesic

Uses:

Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome

Warnings

  • For External Use Only, As Directed!
  • Avoid contact with eyes or other sensitive areas.
  • If prone to allergic reaction from asprin or salicylate, consult your doctor before using.
  • If conditions persist pore than seven days, consult your doctor
  • If pregnant or breast-feeding, ask a health professional before use.
  • Do not bandange tightly or use a heating pad
  • May irritate sensitive skin

Otc - Keep Out Of Reach Of Children

  • Keep ointment out of reach of children

Directions

​Adults and children over 12 years:

  • ​Apply freely to affected areas. Rub well
  • ​Colds: ​Apply on chest, back and neck.
  • ​Head Colds: Apply around nostrils, on forehead and behind ears.  Place small amount in vaporizer for aid.
  • ​Sore Throat:​ Apply  liberally on throat and neck for sore throats

    • Children 12 years or younger.

    • Consult your physician.

Inactive Ingredients

Water, Carthamus Tinctorius (Hybrid Safflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe Barbadensis (Aleo Vera) Leaf Juice, Beeswax, Hydrogenated Castor oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus Globulus Leaf Oil, Chlorphenesin, Cinnamomum Camphora Bark Oil, Abies Sibirica Needle Oil, Methyl Salicylate, Sodium Chloride

Package Label.Principal Display Panel

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