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| Product NDC Code | 59316-101 | ||||||||||||||||||||||
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| Drug Name | Biofreeze |
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| Type | Brand | ||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||
| Dosage Form | GEL | ||||||||||||||||||||||
| RxCUI drug identifier | 808955, 1043451 |
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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 Ingredients Menthol USP 3.5%
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: Rub a thin film over affected areas not more than 4 times daily; massage not necessary. Children under 2 years of age : Consult physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water USP
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 from minor aches and pains of sore muscles and joints associated with: arthritis - backache - strains - sprain
Purpose
Information about the drug product’s indications for use.Purpose Cooling Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.Biofreeze Menthol FD&C BLUE NO. 1 FD&C YELLOW NO. 5 GLYCERIN ISOPROPYL ALCOHOL METHYLPARABEN CAMPHOR (NATURAL) PROPYLENE GLYCOL SILICON DIOXIDE TROLAMINE WATER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM
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.PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label PENETRATING, LONG LASTING PAIN RELIEF FROM: ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN BIOFREEZE ® PAIN RELIEVING Roll-On WITH SOOTHING MENTHOL Cryotherapy - The Cold Method ® 3 fl oz / 89 mL PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump Label PENETRATING, LONG LASTING PAIN RELIEF FROM: ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN BIOFREEZE ® PAIN RELIEVING gel WITH SOOTHING MENTHOL Cryotherapy - The Cold Method ® 16 fl oz / 473 mL PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump 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.Other Information: Store in a cool dry place with lid closed tightly
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have: sensitive 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 the reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.
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? 800-246-3733
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: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.
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 or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with heating pad or device
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding: Ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Flammable Keep away from excessive heat or open flame
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 Ask a doctor before use if you have: sensitive skin When Using This Product Avoid contact with the eyes or mucous membranes Do not apply to wounds or damaged skin Do not use with other ointments, creams, sprays or liniments Do not apply to irritated skin or if excessive irritation develops Do not bandage Wash hands after use with cool water Do not use with heating pad or device Stop Use And Ask A Doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur. If pregnant or breastfeeding: Ask a health professional before use. Keep out of the reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.
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