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Product NDC Code | 35000-745 | ||||
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Drug Name | Colgate re variety pack |
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Type | Brand | ||||
Dosage Form | KIT | ||||
RxCUI drug identifier | 416783 | ||||
Application Number | M021 | ||||
Labeler Name | Colgate-Palmolive Company | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium Fluoride
Active ingredient Sodium Fluoride
Active ingredient Sodium Fluoride
Active ingredient Sodium Fluoride
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 of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise the child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician
Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise the child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician
Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise the child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician
Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise the child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician
adults and children 2 years of age and older | brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician |
children 2 to 6 years | use only a pea sized amount and supervise the child's brushing and rinsing (to minimize swallowing) |
children under 2 years | ask a dentist or physician |
adults and children 2 years of age and older | brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician |
children 2 to 6 years | use only a pea sized amount and supervise the child's brushing and rinsing (to minimize swallowing) |
children under 2 years | ask a dentist or physician |
adults and children 2 years of age and older | brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician |
children 2 to 6 years | use only a pea sized amount and supervise the child's brushing and rinsing (to minimize swallowing) |
children under 2 years | ask a dentist or physician |
adults and children 2 years of age and older | brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician |
children 2 to 6 years | use only a pea sized amount and supervise the child's brushing and rinsing (to minimize swallowing) |
children under 2 years | ask a dentist or physician |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Charcoal Powder, Blue 1, Red 40.
Inactive ingredients Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Blue 1, Yellow 5.
Inactive ingredients Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Propylene Glycol, Pyrus Communis (Pear) Fruit Extract, Red 40.
Inactive ingredients Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Algin, Blue 1.
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.Use helps protect against cavities
Use helps protect against cavities
Use helps protect against cavities
Use helps protect against cavities
Purpose
Information about the drug product’s indications for use.helps protect against cavities
helps protect against cavities
helps protect against cavities
helps protect against cavities
Spl product data elements
Usually a list of ingredients in a drug product.Colgate Re Variety Pack SODIUM FLUORIDE Colgate RE reenergize SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED COCAMIDOPROPYL BETAINE SACCHARIN SODIUM PROPYLENE GLYCOL PYRUS COMMUNIS WHOLE FD&C RED NO. 40 Colgate RE repair SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED COCAMIDOPROPYL BETAINE SACCHARIN SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5 Colgate RE refresh SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED COCAMIDOPROPYL BETAINE SACCHARIN SODIUM ALGINIC ACID FD&C BLUE NO. 1 Colgate RE revive SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA SODIUM LAURYL SULFATE POLYETHYLENE GLYCOL 600 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED COCAMIDOPROPYL BETAINE SACCHARIN SODIUM ACTIVATED CHARCOAL FD&C BLUE NO. 1 FD&C RED NO. 40
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 - Kit Blister Pack Colgate ® dreamtube technology 4 PACK glides on smooth helps you squeeze out every drop! FOUR 3.8 OZ (107 g) TUBES* TOTAL NET WT 15.2 OZ (428 g) PS0025725 PRINCIPAL DISPLAY PANEL - Kit Blister Pack
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.re:vive Drug Facts
re:pair Drug Facts
re:energize Drug Facts
re:fresh Drug Facts
Dist. by: COLGATE-PALMOLIVE CO. New York, NY 10022 U.S.A.
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 under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children under 6 years of age. 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? 1-800-468-6502
Questions? 1-800-468-6502
Questions? 1-800-468-6502
Questions? 1-800-468-6502
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 Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Warnings Keep out of reach of children under 6 years of age. 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