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Product NDC Code | 83035-7120 | ||||
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Drug Name | Tetri-ag |
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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 | 2673693 | ||||
Application Number | M017 | ||||
Labeler Name | Singular Dreamer, Ltd dba True Marker | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Tetracaine 1.9%. 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: do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aqua (Deionized Water), Methylisothiazolinone, PEG-8, PEG-8 Stearate, PEG-100 Stearate, Polyethylene Glycol
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 For the temporary relief of: Pain, associated with Minor burns Minor cuts Scrapes Sunburn
Spl product data elements
Usually a list of ingredients in a drug product.Tetri-AG Tetracaine ALCOHOL WATER METHYLISOTHIAZOLINONE POLYETHYLENE GLYCOL 400 PEG-8 STEARATE PEG-100 STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TETRACAINE TETRACAINE
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.Product label image description
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.Other Information: Store at 20-25 C (68-77F). [see USP Controlled Room Temperature].
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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. Do not use in large quantities over raw surfaces blistered areas on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly Stop use and ask a doctor if : symptoms persist for more than 7 days symptoms clear up and occur again within a few days skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering conditions worsen If pregnant or breast feeding , ask health professional before use. Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center (-1800-222-1222) 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