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The Natural Dentist Orange Zest

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 0.2430g in 100g
Labeler: Caldwell Consumer Health LLC
NDC Code: 34362-0235

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Sodium fluoride 0.24% w/w (0.15% w/v fluoride ion)...............Anticavity

Uses

aids in the prevention of dental cavities

Stop use and ask a dentist if the sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Do not use if safety seal is broken.

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.

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals, at least twice a day or as directed by a dentist. Do not swallow.

Children under 2 years of age: Consult a dentist or physician.

Children under 6: Use a pea sized amount and supervise until good brushing habits are established. Children under 2 years of age: ask a dentist.

Other Information

Store tube standing up with cap tightly closed.

Inactive ingredients

Glycerin, Silica, Water, Sorbitol, Xylitol, Cocamidopropyl Betaine, Aloe barbadensis Leaf Juice, Cellulose Gum, Titanium Dioxide, Echinacea angustifolia Extract, Natural Flavors, Hydrastis canadensis (Goldenseal) Extract, Calendula officinalis Extract, Xanthan Gum, Citric Acid, Citrus grandis (Grapefruit) Seed Extract.

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THE NATURAL DENTIST  ORANGE ZEST
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0235
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2430 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
XYLITOL 
GOLDENSEAL 
ALOE VERA LEAF 
TITANIUM DIOXIDE 
GLYCERIN 
CARBOXYMETHYLCELLULOSE SODIUM 
HYDRATED SILICA 
XANTHAN GUM 
CITRUS PARADISI SEED 
COCAMIDOPROPYL BETAINE 
ECHINACEA ANGUSTIFOLIA LEAF 
CITRIC ACID MONOHYDRATE 
CALENDULA OFFICINALIS FLOWER 
Product Characteristics
Colorwhite (White to Off White) Score    
ShapeSize
FlavorORANGE (Orange Zest) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:34362-0235-1142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2011
Labeler - Caldwell Consumer Health LLC (828558713)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
Lornamead126440440manufacture(34362-0235), pack(34362-0235)

Revised: 05/2013
 
Caldwell Consumer Health LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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