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Product NDC Code | 60306-115 | ||||
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Drug Name | Brace relief |
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Type | Brand | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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Active Ingredients |
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Route | ORAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 1547591, 1547593 |
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Application Number | M004 | ||||
Labeler Name | InfaLab,Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS: Benzocaine 9%
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: Apply to irritated areas as needed See package insert for instructions, warnings & cautions.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: PEG 8, PEG 75, Glycerine, Tincture of Myrrh, Menthol, Phenol, Clove Oil, Methyl Salicylate, Peppermint Oil, Methyl Paraben, Propyl Paraben.
Spl product data elements
Usually a list of ingredients in a drug product.Brace Relief Benzocaine Benzocaine Benzocaine Polyethylene glycol 400 Polyethylene glycol 3350 Glycerin Myrrh Menthol Phenol Clove Oil Methyl Salicylate Peppermint Oil Methylparaben Propylparaben
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.Principal Display Panel – Tube Label INfALAB® MAGIC TOUCH BraceRelief ™ ANESTHETIC GEL IN AN ANTISEPTIC BASE Relieves mouth pain Net Wt. 3 g. NDC#603061155 Principal Display Panel – Tube Label
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.CAUTION: For temporary relief only. Dist.by Infa-Lab Inc., Rockaway, NJ 07866 1996 INFA-LAB INC., Rockaway, NJ
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