Emu Therapy Cool Menthol Therapy Pain Relief Cream
FDA Label NDC 83591-416

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aca Management Llc for the product Emu Therapy Cool Menthol Therapy Pain Relief Cream (NDC 83591-416). 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:, do not use, when using this product, stop use and ask a doctor, 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

Active Ingredient:

Menthol, USP (2.75%)

Purpose:

Topical Analgesic

Uses:

Temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

Warnings:

  • For external use only.

Do Not Use

on wounded, damaged or irritated skin.

When Using This Product

avoid contact with eyes or mucous membranes, do not bandage tightly.

Stop Use And Ask A Doctor

  • if you experience a rash and/or a reaction, condition worsens, or if symptoms persist for more than 10 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:

  • For adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times a day. Consult a doctor before using for children under 2 years of age.

Inactive Ingredients:

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roman Chamomile) Oil, Aqua (Deionized water), Arnica Montana Flower Extract, Ascorbyl Palmitate (Vitamin C), Calendula Officinalis Extract, Capsaicin, Carbomer, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Ethylhexylglycerin, FD&C Blue #1; FD&C Yellow #5, Glycerin, Hamamelis Virginiana (Witch Hazel), Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Lamium Album (White Nettle) Extract, Methylsulfonylmethane (MSM), Parfum (Fragrance), Phenoxyethanol, Salix Alba (Willow) Bark Extract, SD-Alohol 40B, Sodium Lauryl Sulfate, Sorbitol, Tanacetum Parthenium (Feverfew) Extract, Tilla Cordata (Linden) Bark Extract, Triethanolamine.

Questions Or Comments?

1-800-222-0554 or www.coolmentholTheropyPainCream.com

Package Labeling:

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