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| Product NDC Code | 0126-0165 | ||||
|---|---|---|---|---|---|
| Drug Name | Gel-kam fruit and berry |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 237847, 750088 |
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| Application Number | M021 | ||||
| Labeler Name | Colgate Oral Pharmaceuticals, 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 Stannous fluoride 0.4% (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 12 years of age or older: use after regular brushing and flossing shake excess water from your toothbrush and cover bristles with gel brush thoroughly keep on your teeth for one minute and then spit out do not swallow do not rinse, eat or drink for 30 minutes use once a day for cavity protection use twice a day (morning and evening) for sensitivity relief or as recommended by a dentist or physician make sure all sensitive areas are covered by using a toothbrush or a cotton swab supervise children until capable of using without supervision children under 12 years of age: consult a dentist or physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients flavor, glycerin, hydroxyethylcellulose
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 helps protect against cavities builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Purpose
Information about the drug product’s indications for use.Purposes Anticavity/Sensitivity Relief
Spl product data elements
Usually a list of ingredients in a drug product.Gel-Kam Mint Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION GLYCERIN HYDROXYETHYL CELLULOSE, UNSPECIFIED Gel-Kam Fruit and Berry Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION GLYCERIN HYDROXYETHYL CELLULOSE, UNSPECIFIED
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 - 122 g Tube Carton - Mint NDC 0126-0192-93 Colgate ® Gel•Kam ® 0.4% Stable Stannous Fluoride PREVENTATIVE TREATMENT GEL For Cavity Protection and Sensitive Teeth MINT NET WT 4.3 OZ (122 g) PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Mint
PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Fruit and Berry NDC 0126-0165-93 Colgate ® Gel•Kam ® 0.4% Stable Stannous Fluoride PREVENTATIVE TREATMENT GEL For Cavity Protection and Sensitive Teeth FRUIT & BERRY NET WT 4.3 OZ (122 g) PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Fruit and Berry
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
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 this product longer than four weeks for sensitive teeth unless recommended by a dentist or physician.
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 brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call toll free at 1-800-962-2345
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 problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
Storage and handling
Information about safe storage and handling of the drug product.Other information this is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before use this product may produce surface staining of the teeth Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist do not use if embossed seal on tube is broken or missing to open tube, remove cap and pierce foil seal with point of cap keep tightly closed when not in use store at controlled room temperature 68-77°F (20-25°C)
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 this product longer than four weeks for sensitive teeth unless recommended by a dentist or physician. Stop use and ask a doctor if problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children. If more than used for brushing 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