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| Product NDC Code | 77338-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Astonea cold therapy |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 415974 | ||||
| Application Number | M017 | ||||
| Labeler Name | ASTONEA LABS PRIVATE LIMITED | ||||
| 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.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 areas not more than 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.camphor, carbopol 940, DMDM hydantoin, edetate disodium, FD&C yellow no. 5, FD&C blue no. 1, isopropyl alcohol, PEG 40 hydrogenated castor oil, propylene glycol, 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.Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains sprains
Purpose
Information about the drug product’s indications for use.Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.ASTONEA COLD THERAPY Menthol 4% POLYETHYLENE GLYCOL 2000 GLYCERIN DMDM HYDANTOIN EDETATE SODIUM CARBOMER 940 ISOPROPYL ALCOHOL FD&C YELLOW NO. 5 FD&C BLUE NO. 1 HYDROGENATED CASTOR OIL SODIUM HYDROXIDE WATER CAMPHOR (SYNTHETIC) MENTHOL MENTHOL
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 and Drug Fact Panel
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 Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
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 accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)
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 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 alter 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
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.For external use only Flammable: Keep away from excessive heat or open flame Ask a doctor before use if you have : sensitive skin Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. When using this product ■avoid contact with 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 alter use with cool water ■do not use with heating pad or device If pregnant or breastfeeding , ask a health professional before use Keep out of reach of children: If accidentally ingested, get medical help or contact a poison Control immediately (1800-222-1222)
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