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| Product NDC Code | 55319-990 | ||||
|---|---|---|---|---|---|
| Drug Name | Family wellness ice blue |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 311502 | ||||
| Application Number | part348 | ||||
| Labeler Name | FAMILY DOLLAR SERVICES 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 ingredient Menthol 2 percentage
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 Adult and children 2 years of age and older: Clean skin thoroughly. Apply liberally to affected area not more than 3-4 times daily. No protective cover needed. May be used with ice packs. May be used with wet or dry bandages, but wrap loosely. Children under 2 years of age, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Blue 1, Camphor, Carbomer, Isopropyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide, 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 pains of muscle and joints associated with simple back ache arthritis sprains, strains or bruises
Purpose
Information about the drug product’s indications for use.Purpose External pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.FAMILY WELLNESS ICE BLUE MENTHOL METHYLISOTHIAZOLINONE WATER MENTHOL MENTHOL CAMPHOR (SYNTHETIC) ISOPROPYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE SODIUM HYDROXIDE CARBOMER 934 FD&C BLUE NO. 1
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.label
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. DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE. In case of accidental ingestion, get medical help or contact a Posion Control Center immediately.
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 and occur again within a few days skin 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 Use only as directed do not bandage tightly avoid contact with eyes and mucus membranes
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)If you are pregnant or nursing a baby, concult a physician before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 59 - 86 Fahrenheit (15 - 30 degrees Celsius) keep tightly closed do not use, pour, spill or store near 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 Do not use internally, with heating pads or devices, on wounds or damaged skin. For external use only. Ask a doctor before use if you have sensitive skin.
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