THE NATURAL DENTIST PEPPERMINT TWIST- fluoride paste, dentifrice 
Caldwell Consumer Health LLC

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.

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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, Hydrated Silica, Sorbitol, Water, Xylitol, Cocamidopropyl Betaine, Sodium Cocoyl Glycinate, Aloe Barbadensis Leaf Juice, Cellulose Gum, Titanium Dioxide, Echinacea Angustifolia Extract, Natural Flavors, Hydrastis Canadensis (Goldenseal) Extract, Calendula Officinalis Extract, Xanthan Gum, Citric Acid, Zinc Citrate, Citrus Grandis (Grapefruit) Seed Extract.

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Tube Label

THE NATURAL DENTIST  PEPPERMINT TWIST
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0234
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2430 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
ZINC CITRATE (UNII: K72I3DEX9B)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
Product Characteristics
Colorwhite (Off White) Score    
ShapeSize
FlavorPEPPERMINT (Peppermint Twist) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34362-0234-1142 g in 1 TUBE; Type 0: Not a Combination Product05/01/201105/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/201105/01/2018
Labeler - Caldwell Consumer Health LLC (828558713)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(34362-0234) , pack(34362-0234)

Revised: 5/2018
 
Caldwell Consumer Health LLC