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Product NDC Code | 34362-0237 | ||||
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Drug Name | Peppermint twist |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | PASTE, DENTIFRICE | ||||
RxCUI drug identifier | 891775 | ||||
Application Number | M022 | ||||
Labeler Name | Caldwell Health LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium fluoride (0.24%) (0.15% w/v fluoride ion)
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 or as directed by a dentist or physician. Children 2 to 6 years Use only a pea-sized amount and supervise 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 or as directed by a dentist or physician. |
Children 2 to 6 years | Use only a pea-sized amount and supervise 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 Glycerin, hydrated silica, sorbitol, water, xylitol, Aloe barbadensis leaf juice, cocamidopropyl betaine, sodium cocoylglycinate, cellulose gum, titanium dioxide, Echinacea angustifolia extract, natural flavors (contains Cinnamomum cassie leaf oil), Hydrastis canadensis (goldenseal) extract, Calendula officinalis extract, xanthan gum, citric acid, zinc citrate, Citrus grandis (grapefruit) seed extract.
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 Aids in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Peppermint Twist Fluoride GLYCERIN HYDRATED SILICA SORBITOL WATER XYLITOL ALOE VERA LEAF COCAMIDOPROPYL BETAINE SODIUM COCOYL GLYCINATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM TITANIUM DIOXIDE ECHINACEA ANGUSTIFOLIA GOLDENSEAL CALENDULA OFFICINALIS FLOWER XANTHAN GUM CITRIC ACID MONOHYDRATE ZINC CITRATE CITRUS MAXIMA SEED SODIUM FLUORIDE FLUORIDE ION Off White Peppermint Twist
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.NO SLS! THE NATURAL DENTIST ALL IN ONE FLUORIDE TOOTHPASTE with Purified Aloe Vera Prevents Cavities Whitens Teeth Strengthens Tooth Enamel Fights Tartar Freshens Breath PEPPERMINT TWIST NET WT. 5.0 OZ (141g) image description
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
Manufactured for Revive Personal Products Company, Allendale, NJ 07401 © 2018 Revive Personal Products Company. Made in USA. Vegan. Not tested on animals.
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. Do not use if the safety seal is missing or broken.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-317-4402, weekdays 9 to 5 ET.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store standing up with cap tightly closed.
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. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if the safety seal is missing or broken.
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