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| Product NDC Code | 55715-001 | ||||||||
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| Drug Name | Zepol topical analgesic |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OINTMENT | ||||||||
| RxCUI drug identifier | 1044238 | ||||||||
| Application Number | M017 | ||||||||
| Labeler Name | Laboratorios Zepol S.A. | ||||||||
| 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 Camphor 6.55% Menthol 6.55% Purpose Topical Analgesic
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: Apply to affected area not more than 3 to 4 times daily. -Children under 2 years of age: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Eucalyptol, Petrolatum, Thyme Oil, Turpentine Oil Rectified.
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 For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, strains, bruises and sprains.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Zepol Topical Analgesic Camphor, Menthol EUCALYPTOL PETROLATUM TURPENTINE THYME OIL CAMPHOR (SYNTHETIC) 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.Zepol Topical Analgesic 1 oz
Zepol Topical Analgesic Outer Box
Package Labeling: Outer Package Inner Package
Package Labeling: Outer Package2 Inner Package2
Zepol Topical Analgesic Ointment,12 units (0.35oz/10g) (55715-001-12) Label Label1 Label2
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
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 apply to wounds or damaged skin. Do not bandage tightly.
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 Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 30 degrees C (86 degrees F).
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. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Do not apply to wounds or damaged skin. Do not bandage tightly. Keep out of reach of children. If swallowed, get medical help or contact 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