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| Product NDC Code | 82810-115 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Aldamed |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Green Idea s.r.o. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Camphor 3% ….……………………………………………………………………..…..Topical Analgesic, Topical Antitussive Menthol 2% …...…………………..…………………..………………………………...Topical Analgesic, Topical Antitussive Eucalyptus Oil 1%...........................................................................................................................................Topical Antitussive
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 for adults & children two years of age and over: rub a thick layer on the chest and throat or rub on aching muscles, and cover with a warm, dry cloth if desired. keep clothing loose about the throat/chest to help vapors reach the nose/mouth repeat up to three times per 24 hours or as directed by a doctor for children under two years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient amyris balsamifera bark oil arctium lappa root extract butyrospermum parkii butter cedrus deodara wood oil cera alba cocos nucifera oil chamomilla recutita (matricaria) flower extract cupressus sempervirents oil eugenia caryophyllus leaf oil helianthus annuus seed oil hyssopus officinalis herb oil juniperus communis fruit oil macadamia integrifolia seed oil mentha piperita oil pinus pumila twig leaf oil pinus sylvestris twig leaf oil (pine needle oil) prunus amygdalus dulcis oil (almond oil) rosmarinus officinalis leaf oil salix alba bark extract thymus vulgaris oil tocopheryl acetate - Alpha-tocopherol acetate
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.Use Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, simple backache, bruises, strains, and sprains.
Purpose
Information about the drug product’s indications for use.on chest and throat, temporarily relieves cough due to common cold
Spl product data elements
Usually a list of ingredients in a drug product.Aldamed Vaporizing Chest Rub Cough Suppressant .ALPHA.-TOCOPHEROL ACETATE WILLOW BARK CLOVE LEAF OIL HYDROGENATED COCONUT OIL AMYRIS BALSAMIFERA OIL PINE NEEDLE OIL (PINUS MUGO) JUNIPER BERRY OIL ROSEMARY OIL THYME OIL PEPPERMINT OIL CHAMOMILE MACADAMIA OIL WHITE WAX ARCTIUM LAPPA ROOT ALMOND OIL HYSSOP OIL SUNFLOWER OIL CUPRESSUS SEMPERVIRENS LEAF OIL CEDRUS DEODARA WOOD OIL SHEA BUTTER CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL MENTHOL EUCALYPTUS OIL EUCALYPTUS OIL
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.125 mL NDC: 82810-115-11 ChestRub Outer ChestRub NDC
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 a cough that occurs with excessive phlegm (mucus) have persistent or chronic cough such as occurs with smoking, asthma or emphysema are pregnant, or breastfeeding
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 immediately at 1-800-222-1222.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store in a cool, and dry place and avoid freezing and excessive heat Do not expose the product to the 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 the cough persists for more than seven days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a severe condition.
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 Do not take by mouth or place in nostrils on wounds or damaged skin or with tight bandages
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. Avoid contact with eyes. Do not heat, microwave, or add to hot water or any container heating water. This may result in splatter and skin burns.
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