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| Product NDC Code | 77338-015 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Astonea green gel |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| RxCUI drug identifier | 415975 | ||||||||
| 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.Active Ingredients Menthol 5% Purpose Pain Relieving
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: consult a physician ■Wash hands after use with cool water
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients : Aloevera Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Calendula Officinalis Extract, Carbopol, FD&C Blue No. 1, FD&C Yellow No. 5, Glycerine, Green Tea Extract, Isopropyl Alcohol, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, 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
Spl product data elements
Usually a list of ingredients in a drug product.ASTONEA GREEN gel MENTHOL FD&C BLUE NO. 1 SILICON DIOXIDE FD&C YELLOW NO. 5 ALOE VERA LEAF ARCTIUM LAPPA ROOT ARNICA MONTANA FLOWER CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CARBOXYPOLYMETHYLENE GLYCERIN ISOPROPYL ALCOHOL ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL TROLAMINE WATER 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.Package Labeling: Principal Display and Drug Fact Panel
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.Drug Facts
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.■Store at 20˚-25˚C (68˚-77˚F) ■Store in a cool dry place away from direct sunlight
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: ■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 ■Arthritis pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age
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 the eyes or on 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 device
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 Flammable: Keep away from excessive heat or open flame. When using this product: ■Use only as directed ■Avoid contact with the eyes or on 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 device 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 ■Arthritis pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age If pregnant or breast-feeding: Ask a health professional before use 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