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| Product NDC Code | 72524-641 | ||||
|---|---|---|---|---|---|
| Drug Name | Ay bendito - thermoactive |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M017 | ||||
| Labeler Name | AY BENDITO INTERNATIONAL, 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.Camphor ………………. 6% 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.Adults and Children over 12 years of age Apply a small amount on the affected area. Massage in circular motion, let set for a few seconds. Repeat as necessary, but no more than 3 to 4 times daily. Children under 12 years of age: do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water (Aqua), Alcohol Denat, Glycerin, Paraffinum Liquidum, Triethanolamine, Arnica Montana Flower Extract, Polysorbate 20, Carbomer, Methyl Salicylate, Sodium Chondroitin Sulfate, Glucosamine Sulfate, Rosmarinus Officinalis (Rosemary) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue No.1 (CI 42090).
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.Aid for temporary local relief of minor pain in muscles or joints.
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.AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL TROLAMINE MINERAL OIL SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) WATER GLYCERIN ARNICA MONTANA FLOWER WATER METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE POLYSORBATE 20 METHYL SALICYLATE ROSMARINUS OFFICINALIS FLOWERING TOP FD&C BLUE NO. 1 CAMPHOR (NATURAL) CAMPHOR (NATURAL) CARBOMER 940 GLUCOSAMINE SULFATE 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.AY BENDITO THERMOACTIVE CREAM TUBE AY BENDITO THERMOACTIVE CREAM TUBE
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.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 Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTION OR COMMENTS? Call: +1-787-421-6423
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 Redness is present Irritation develops Symptoms persist for more than 7 days or clear up occur again within a few days You experience signs injury, such as pain, swelling or blistering where the product was applied.
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.Use only as directed Do not bandage tightly or use with a heating pad Avoid contact with eyes and mucous membranes Do not apply to wounds or damaged, broken or irritated skin A transient burning sensation or redness may occur upon application but generally disappears in several days If you experience an allergic reaction, discontinue use and consult a doctor Do not expose the area treated with product to heat or direct sunlight.
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.For external use only.
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