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| Product NDC Code | 10742-8915 | ||||
|---|---|---|---|---|---|
| Drug Name | Red cross canker sore |
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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 | OINTMENT | ||||
| RxCUI drug identifier | 244323, 1489070 |
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| Application Number | part356 | ||||
| Labeler Name | The Mentholatum Company | ||||
| 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 snip off tip of tube apply to affected area; carefully coat with a protective layer supervise children using this product adults and children 2 years and over: use up to 4 times daily or as directed by a doctor children under 2 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aloe barbadensis leaf extract, butylated hydroxytoluene, carbomer hompolymer, cetylpyridinium chloride, chamomilla recutita (matricaria) flower extract, cocos nucifera (coconut) oil, commiphora myrrha resin, dimethicone, echinacea purpurea extract, flavor, glyceryl stearate, menthol, mineral oil, silica dimethicone silylate, vitamin E, white petrolatum
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 temporarily relieves pain and minor irritation of the mouth and gums due to ▪ canker sores ▪ minor dental procedures ▪ braces ▪ dentures
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic/analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Red Cross Canker Sore benzocaine ALOE VERA LEAF BUTYLATED HYDROXYTOLUENE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYLPYRIDINIUM CHLORIDE CHAMOMILE COCONUT OIL MYRRH ECHINACEA PURPUREA GLYCERYL 1-STEARATE MENTHOL, UNSPECIFIED FORM MINERAL OIL SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL PETROLATUM 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.Package/Label Principal Display Panel Red Cross Canker Sore Oral Anesthetic/Analgesic
Principal Display Panel
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.Do Not Use 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 If more than used for pain is accidentally swallowed, 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 sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops
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 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 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 Do Not Use for teething in children under 2 years of age When using this product do not use for more than 7 days unless directed by a dentist or doctor do not exceed recommended dosage Stop use and ask a doctor if sore mouth symptoms last more than 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops
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