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| Product NDC Code | 70769-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Cainetips |
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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 | LIQUID | ||||
| RxCUI drug identifier | 798072 | ||||
| Application Number | part348 | ||||
| Labeler Name | J MORITA USA INC | ||||
| 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 INGREDIENT BENZOCAINE 20%
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 HOLD WITH SOLID WHITE TIP STRAIGHT DOWN; BEND AND SNAP OPEN UPPER TIP AT COLORED RING; ALLOW MEDICINE TO FLOW DOWN. APPLY PRODUCT TO INTENDED AREA; ALLOW IT TO REMAIN IN PLACE AT LEAST 1 MINUTE AND THEN REMOVE IT FROM MOUTH; DISPOSE AFTER APPLICATION. USE UP TO 4 TIMES DAILY, OR AS DIRECTED BY A DENTIST. ADULT SUPERVISION REQUIRED FOR USE WITH CHILDREN UNDER 12 YEARS. CONSULT A DENTAL PROFESSIONAL FOR USE WITH CHILDREN UNDER 2 YEARS.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS ARTIFICIAL FLAVOR, POLYETHYLENE GLYCOL, ETHOXY DIGLYCOL
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 pain due to: minor dental procedures, minor mouth and/or gum irritation caused by dentures or orthodontic appliances, Vincent's infection, or canker sores.
Purpose
Information about the drug product’s indications for use.PURPOSE PAIN RELIEVER
Spl product data elements
Usually a list of ingredients in a drug product.CaineTips BENZOCAINE POLYETHYLENE GLYCOL 1000 DIETHYLENE GLYCOL MONOETHYL ETHER BENZOCAINE BENZOCAINE
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.Canine Tips_Drug Facts Box Canine Tips_Product Image caninetips_ps_0809_v1
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.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)If pregnant or breast feeding, ask a health professional before use.
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 Do not use: if patient is allergic to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics; exceeding recommended dosage for more than 7 days unless directed by a dentist; if sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see a dentist or a physician promptly.
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