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| Product NDC Code | 66902-116 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Fast freeze pain relieving |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| Application Number | part348 | ||||||
| Labeler Name | NATURAL ESSENTIALS, INC. | ||||||
| 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 3.5%
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/Children 2 years and older: Roll on the affected area not more than 3 to 4 times daily Shake well before use Children under 2 years old: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Extract, Carbomer, dl-alpha Tocopheryl Acetate, dl-Camphor, Isopropyl Alcohol, Mate (Ilex Paraguariensis) Extract, Methylparaben, Triethanolamine, Water.
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: Simple backache Arthritis Strains Sprains
Purpose
Information about the drug product’s indications for use.Purpose Cooling Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.Fast Freeze Pain Relieving MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALOE VERA LEAF CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CAMPHOR (SYNTHETIC) .ALPHA.-TOCOPHEROL ACETATE ISOPROPYL ALCOHOL METHYLPARABEN ILEX PARAGUARIENSIS LEAF TROLAMINE WATER
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 Container Label FAST FREEZE® Naturally Cool Pain Relieving Roll-On Helps to relieve Sore muscles Strains & sprains Joint pain Invigorating, cooling menthol Greaseless & stain-free Natural ingredients include Vitamin E, Aloe & Ilex 3 oz (89 mL) Principal Display Panel - 89 mL Container Label
Principal Display Panel - 120 mL Tube Label FAST FREEZE ® Naturally Cool Pain Relieving Gel Helps to relieve Sore muscles Strains & sprains Joint pain Invigorating, cooling menthol Greaseless & stain-free Natural ingredients include Vitamin E, Aloe & Ilex Net wt. 4 oz (113 g) Principal Display Panel - 120 mL Tube 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 With heating pad or device With ointments, creams, sprays or liniments On wounds, damaged skin 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Replace cap after use Store in a cool, dry place
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 317-228-1144 or visit www.Bell-Horn.com or www.fastfreeze.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 Condition worsens Symptoms persist for more than 7 days or clear up then reoccur again within a few days Irritation develops
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
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 Do not use With heating pad or device With ointments, creams, sprays or liniments On wounds, damaged skin or irritated skin Ask a doctor before use if you Have sensitive skin Are pregnant or breastfeeding When using this product Avoid contact with eyes or mucous membranes Do not bandage tightly Stop use and ask a doctor if Condition worsens Symptoms persist for more than 7 days or clear up then reoccur again within a few days Irritation develops 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