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Product NDC Code | 55910-816 | ||||||
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Drug Name | Dg 3x medicated toothache adn gum gel |
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Type | Brand | ||||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [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 | 2362013 | ||||||
Application Number | part356 | ||||||
Labeler Name | Dollar General | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%
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.cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to teh cavity and around the gum surrounding the teeth * use up to 4 times daily or as directed by a dentist or doctor * children under 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid
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.for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums
Purpose
Information about the drug product’s indications for use.Oral pain reliever Oral pain reliever Oral astringent
Spl product data elements
Usually a list of ingredients in a drug product.DG 3x Medicated Toothache adn Gum Gel Benzocaine POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM SACCHARIN BENZOCAINE BENZOCAINE ZINC CHLORIDE ZINC CATION SORBIC ACID AMMONIUM GLYCYRRHIZATE GLYCYRRHIZIN MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM Cloudy White to Yellow
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.Tube Artwork
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. In case of overdose, 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.do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use continuously * this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying * retain carton for complete product information
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.Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics Do not use * more than directed * for more than 7 days uness told to do so by a dentist or doctor * for teething * in children under 2 years of age Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergeic reaction occurs Keep out of reach of children. In case of overdose, 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