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| Product NDC Code | 61734-030 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Vaporizing colds rub |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 200293 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Delon Laboratories (1990) Ltd | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Camphor 4.7% Eucalyptus oil 1.2% Menthol 2.6%
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 see important warnings under "When using this product" adults and children 2 years and older: rub on the throat and chest in a thick layer cover with a warm, dry cloth if desired clothing should be loose about throat and chest to help vapors reach the nose and mouth use up to three times daily or as directed by a doctor children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cedar leaf oil, petrolatum, thymol, turpentine
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: cough due to minor bronchial irritation associated with a cold or inhaled irritants cough associated with a cold minor aches and pains of muscles and joints
Purpose
Information about the drug product’s indications for use.Purpose Cough suppressant & topical analgesic Cough suppressant Cough suppressant & topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Vaporizing Colds Rub Menthol PETROLATUM CEDAR LEAF OIL THYMOL TURPENTINE MENTHOL MENTHOL EUCALYPTUS OIL EUCALYPTUS OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC)
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.Penetro 1.75oz Penetro Vaporizing Medicated Rub 1.75oz Box Penetro Vaporizing Medicated Rub 1.75oz label
Delon 4oz (113g) Delon Vaporizing Colds Rub 113g
Penetro 4oz Penetro Vaporizing Medicated Rub 4oz box Penetro Vaporizing Medicated Rub 4oz label
PII 4 OZ PII Vaporizing Colds Rub 4 oz
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 excessive phlegm (mucus) emphysema persistent or chronic cough asthma cough associated with smoking
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use: by mouth on wounds or damaged skin in nostrils with tight bandages
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.Other information store at room temperature
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 muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days cough perists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious 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 heat microwave add to hot water or any container where heating water. May cause splattering and result in burns.
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; avoid contact with eyes. Do not use: by mouth on wounds or damaged skin in nostrils with tight bandages Ask a doctor before use if you have excessive phlegm (mucus) emphysema persistent or chronic cough asthma cough associated with smoking When using this product, do not heat microwave add to hot water or any container where heating water. May cause splattering and result in burns. Stop use and ask a doctor if muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days cough perists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. 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