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Emu therapy cool menthol therapy pain relief cream - Medication Information

Product NDC Code 83591-416
Drug Name

Emu therapy cool menthol therapy pain relief cream

Type Brand
Active Ingredients
Menthol 27.5 mg/ml
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 2643471
Application Number M017
Labeler Name ACA MANAGEMENT LLC
Packages
Package NDC Code Description
83591-416-00 237 ml in 1 jar (83591-416-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient: Menthol, USP (2.75%) Purpose: Topical Analgesic

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses: Temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

Purpose

Information about the drug product’s indications for use.
Purpose: Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
EMU THERAPY Cool Menthol Therapy Pain Relief Cream MENTHOL ALOE VERA LEAF WATER ARNICA MONTANA FLOWER ASCORBYL PALMITATE CALENDULA OFFICINALIS FLOWER CAPSAICIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CHAMOMILE CORIANDER EMU OIL ETHYLHEXYLGLYCERIN FD&C BLUE NO. 1 FD&C YELLOW NO. 5 GLYCERIN HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HYPERICUM PERFORATUM WHOLE LAMIUM ALBUM WHOLE DIMETHYL SULFONE PHENOXYETHANOL SALIX ALBA BARK SODIUM LAURYL SULFATE SORBITOL FEVERFEW TROLAMINE MENTHOL MENTHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package Labeling: Label

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on wounded, damaged or irritated skin.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or Comments? 1-800-222-0554 or www.coolmentholTheropyPainCream.com

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or Breast-Feeding ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API