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| Product NDC Code | 84093-442 | ||||
|---|---|---|---|---|---|
| Drug Name | Hav ez penetrating pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M017 | ||||
| Labeler Name | PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Menthol 3.00 % 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: Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Amica Montana Flower Extract, Boswellia Carterii (Frankincense) Oil, Cannabis Saliva (Hemp) Seed Oil, Caprylic/Capric Triglyceride, Cinnamomum Cassia Leaf Oil, Curcuma Longa (Turmeric) Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Ilex Paraguariensis (Yerba Mate') Extract, Magnesium Sulfate, Olea Europaea (Olive) Oil, Phenoxyethanol, Piper Nigrum (Black Pepper) Extract, Polysorbate-20, Propylene Glycol, 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 of muscles and joints, associated with • arthritis simple backache • strains • bruises • sprains.
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.HAV EZ Penetrating Pain Relief MENTHOL ALOE VERA LEAF WATER FRANKINCENSE HEMP MEDIUM-CHAIN TRIGLYCERIDES CHINESE CINNAMON LEAF OIL TURMERIC ETHYLHEXYLGLYCERIN EUCALYPTUS OIL GLYCERIN MAGNESIUM SULFATE, UNSPECIFIED FORM GREEN OLIVE PHENOXYETHANOL BLACK PEPPER POLYSORBATE 20 PROPYLENE GLYCOL 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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information: Protect the product in this container from excessive heat and direct sun
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 damaged or broken 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.954-747-1221
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 Rash or irritation develops and lasts Condition worsens, or if symptoms persist for more than 7 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 the eyes. Do not bandage tightly.
Pregnancy or breast feeding
Pregnancy or Breast feedingIF 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.Warning: For external use only Do not use: On damaged or broken skin When using this product Avoid contact with the eyes. Do not bandage tightly. Stop use and ask a doctor if Rash or irritation develops and lasts Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. IF PREGNANT OR BREAST FEEDING ask a health professional before use
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