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| Product NDC Code | 70372-729 | ||||
|---|---|---|---|---|---|
| Drug Name | Blt 3 |
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| Type | Brand | ||||
| Pharm Class | Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1858385 | ||||
| Application Number | M017 | ||||
| Labeler Name | CENTURA PHARMACEUTICALS 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.ACTIVE INGREDIENT Tetracaine 2%
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 two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Aqua (Deionized Water), PEG-8 Stearate, PEG-100 Stearate, PEG8, PEG-75,Methylisothiazolinone
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 pain and itching.
Purpose
Information about the drug product’s indications for use.PURPOSE Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.BLT 3 TETRACAINE TETRACAINE TETRACAINE WATER PEG-100 STEARATE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 METHYLISOTHIAZOLINONE PEG-8 STEARATE
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 BLT3
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
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Store below 77° F (25° C). Avoid direct sunlight.
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 or mucus membranes. • Do not apply to open or damaged skin. • If condition worsens or symptoms persist for more than seven days, discontinue use and consult physician. • If pregnant or breast feeding,contact physician prior to use. • Keep out of reach of children. If swallowed, contact Poison Control Center. • Do not use if allergic to any ingredient in ointment. • Do not use in large quantities, particularly over raw surfaces or blistered areas.
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