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| Product NDC Code | 69678-143 | ||||
|---|---|---|---|---|---|
| Drug Name | Kens pain and arthritis formula |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M017 | ||||
| Labeler Name | EEZAWAY RELIEF INC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Menthol 2.75%
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 over 12 years: • shake well before using every time • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 3 to 4 times daily • MAKE SURE YOU SHAKE BOTTLE BEFORE EVERY TIME YOU APPLY IT children 12 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Emu Oil, Carbomer, Full Spectrum Hemp Oil (Cannabidiol), PPG-20 Methyl Glucose Ether, Isopropyl Alcohol USP, Oleth-10, PEG-75 Lanolin, Purified Water, Sodium Thiosulfate Pentahydrate, Tincture of Iodine.
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 temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps
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.KENS PAIN AND ARTHRITIS FORMULA MENTHOL MENTHOL, UNSPECIFIED FORM MENTHOL EMU OIL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CANNABIS SATIVA SEED OIL PPG-20 METHYL GLUCOSE ETHER ISOPROPYL ALCOHOL OLETH-10 PEG-75 LANOLIN WATER SODIUM THIOSULFATE IODINE
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.Packaging image description
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
Pain Relief CBD Roll-On 5,000mg of CBD for temporary relief of minor aches and pains associated with ARTHRITIS SIMPLE ACHES AND PAINS SORE AND TIRED MUSCLES SHAKE WELL BEFORE EVERY USE Eezaway Relief Inc. Please Call 800-898-3755 www.kenspainrelief.com MADE IN USA
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.
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 When using this product • use only as directed • do not bandage tightly or use with heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • a transient burning sensation or redness may occur upon application but generally disappears in several days • if severe burning sensation occurs, discontinue use immediately • do not expose the area treated with product to heat or direct sunlight Stop use and ask a doctor if • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days Flammable • keep away from fire or flame 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