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 2 to 6 years of age: 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

Hydrated Silica, Glycerin, Sorbitol, Water, Xylitol, Cocamidopropyl Betaine, Sodium Cocoyl Glycinate, Aloe barbadensis Leaf Juice, Cellulose Gum, Citrus grandis (Grapefruit) Seed Extract, Titanium Dioxide, Xanthan Gum, Flavor.

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Tube Label

THE NATURAL DENTIST  PEPPERMINT TWIST
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0270
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Product Characteristics
Colorwhite (Off White) Score    
ShapeSize
FlavorMINT (Cinnimon Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34362-0270-1142 g in 1 TUBE; Type 0: Not a Combination Product12/01/2020
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 (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(34362-0270) , pack(34362-0270)

Revised: 1/2021
Document Id: 69afa189-a8a5-4e0e-8c7b-db5e35ac4fee
Set id: 2765b320-9a53-4b8c-8932-c5d2c7912da0
Version: 4
Effective Time: 20210125
 
Caldwell Consumer Health LLC