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| Product NDC Code | 59316-121 | ||||
|---|---|---|---|---|---|
| Drug Name | Biofreeze overnight gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 415974, 1111683 |
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| Application Number | part348 | ||||
| Labeler Name | RB Health (US) 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 Active ingredient Menthol 4% Purpose-Pain Relieving Gel
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 Directions ¢ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ¢ children under 2 years of age: consult a physician ¢ wash hands after use with cool water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive ingredients Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine
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 Uses Temporarily relieves minor aches and pains of muscles and joints associated with: ¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains
Purpose
Information about the drug product’s indications for use.Temporarily relieves minor aches and pains of muscles and joints associated with: ¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains
Spl product data elements
Usually a list of ingredients in a drug product.Biofreeze Overnight Gel Menthol MENTHOL MENTHOL ALOE VERA LEAF ARCTIUM LAPPA ROOT .ALPHA.-TOCOPHEROL ACETATE ISOPROPYL ALCOHOL MELISSA OFFICINALIS LEAF CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ILEX PARAGUARIENSIS LEAF WATER TROLAMINE FRANKINCENSE ARNICA MONTANA FLOWER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF ALCOHOL GLYCERIN
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.NDC 59316-121-10 BiOFREEZE® GEL MENTHOL-PAIN RELIEVING GEL 3 FL OZ 89 mL 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 Dist. by: RB Health (US) Parsippany, NJ 07054-0224
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Info Other information ¢ store at 20-25°C (68-77°F) ¢ store in a cool dry place away from direct sunlight
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? 1-800-246-3733
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 Flammable: Keep away from excessive heat or open flame When using this product: • Use only as directed • Avoid contact with the eyes or on mucous membranes • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not bandage tightly or use with heating pad or device •Children 2 years to under 12 years of age:Use only under adult supervision Stop use and ask a doctor if: You experience pain, swelling or blistering of the skin; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days; arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age If pregnant or breastfeeding: 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