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| Product NDC Code | 21130-824 | ||||
|---|---|---|---|---|---|
| Drug Name | Signature care menthol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| Application Number | M017 | ||||
| Labeler Name | Safeway | ||||
| 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 4%
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 area not more than 3 to 4 times daily Children under 2 years of age: ask a doctor wash hands after use with cool water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C BLUE NO.1, FD&C YELLOW NO.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer,Tocopheryl Acetate, 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 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.Purpose Pain Relieving Gel
Spl product data elements
Usually a list of ingredients in a drug product.Signature Care Menthol Menthol 4% CARBOMER 940 MENTHOL MENTHOL GLYCERIN .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF FD&C BLUE NO. 1 CAMELLIA SINENSIS LEAF METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER WATER CAMPHOR (NATURAL) ARNICA MONTANA FLOWER MELISSA OFFICINALIS LEAF BOSWELLIA SERRATA EXTRACT ARCTIUM LAPPA WHOLE CALENDULA OFFICINALIS FLOWER ISOPROPYL MYRISTATE AMINOMETHYL PROPANOL ISOPROPYL ALCOHOL ILEX PARAGUARIENSIS LEAF FD&C YELLOW NO. 5
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 label
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.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.
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 and pets If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) 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 store at 68-77 F (20-25 C) 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 and comments Call 1-866-326-1313
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 avoid contact with eyes or 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 devise
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding ask a health professional before use
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 keep away from fire or flame
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