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| Product NDC Code | 79481-0610 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | 4x medicated severe toothache and 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 | 2369638 | ||||||||
| Application Number | part356 | ||||||||
| Labeler Name | Meijer | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Benzalkonium chloride 0.13% ..................................Oral antiseptic Benzocaine 20% .....................................................Oral pain reliever Menthol 0.5% ........................................................Oral pain reliever Zinc chloride 0.15% ................................................Oral astringent
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.Other Information Other information • 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid I
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.Directions Directions •cut open tip of tube on score mark • adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by children under 12 years of age should be supervised in the use of this product • children under a dentist or doctor • 2 years of age: do not use
Purpose
Information about the drug product’s indications for use.Use for the temporary relief of pain due to toothaches to help protect against infection of minor oral irritation
Spl product data elements
Usually a list of ingredients in a drug product.4x Medicated Severe Toothache and Gum Gel Benzalkonium chloride POLYETHYLENE GLYCOL 3350 SORBIC ACID BENZALKONIUM CHLORIDE BENZALKONIUM BENZOCAINE BENZOCAINE ZINC CHLORIDE ZINC CATION FD&C BLUE NO. 1 SACCHARIN SODIUM SACCHARIN MENTHOL MENTHOL AMMONIUM GLYCYRRHIZATE GLYCYRRHIZIN POLYETHYLENE GLYCOL 400
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.NDC 41250- 061-19 *Compare to the active ingredient in Orajel™ 4X Medicated For Toothache & Gum Gel 4X MEDICATED toothache & gum pain relief gel Immediate Pain Relief 20% Benzocaine to Relieve Oral Pain Antiseptic to Kill Harmful Batceria Astringent to Help Prevent Infection Menthol to cool Gum & Relieves Irritation Carton R2
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.• more than directed • for more than 7 days unless told to do so by a dentist or doctor • for teething • in children under 2 years of age
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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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 • allergic reaction occurs
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.Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy 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 • more than directed • for more than 7 days unless 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 • allergic 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