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| Product NDC Code | 42961-810 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Dental 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 | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 308657 | ||||||
| Application Number | M022 | ||||||
| Labeler Name | Cintas Corporation | ||||||
| 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 Ingredients Benzocaine 20% (w/w)
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 and older: dry affected area and apply medication undiluted; Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor Consult a dentist or doctor for use on children under 2 years of age Children under 12 years of should be supervised in the use of this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients PEG 400, PEG 3350, peppermint oil, 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.Uses For temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.
Purpose
Information about the drug product’s indications for use.Purpose Oral antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Dental Relief benzocaine benzocaine benzocaine polyethylene glycol 400 polyethylene glycol 3350 peppermint oil saccharin sodium sorbic acid
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 – 0.5 gram Packet Dental Relief Active ingredients: Benzocaine (20%), Compound benzoin tincture USES: Temporarily relieves pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor mouth and gum injuries. Do not use if packet is torn or broken NET WT 0.5g dental-01
Principal Display Panel – Pocket Card DENTAL RELIEF PROFESSIONAL STRENGTH RELIEVES DENTAL PAIN COMPARE TO ORAJEL SEE DRUG FACTS CARD FOR COMPLETE WARNINGS 560718 12/13 Xpect First aid dental-02
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.Drug Facts Dental Relief
Other information Do not use if packet is torn, cut or opened Store at room temperature, 15° to 30°C (59° to 86°F) Avoid contact with eyes
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. If more than used for pain relief and protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.
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 oral use only Allergy alert Do not use this product if you have a history of allergy to local anaesthetics, such as procaine, butacaine, benzocaine, or other “caine” anaesthetics due to the possibility of anaphylactic shock. When using this product Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage. Keep out of reach of children. If more than used for pain relief and protection is accidentally swallowed, 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