THE NATURAL DENTIST PEPPERMINT SAGE- peppermint 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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The Natural Dentist Fluoride Free Toothpaste

Active ingredient

Peppermint Oil 0.1% w/w................................................... Antigingivitis / Antiplaque

Sage Oil 0.02% w/w ..........................................................Antigingivitis / Antiplaque

Uses

Helps prevent gingivitis and reduce plaque

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if safety seal is broken. Ask a dentist if symptoms persist or worsen after regular use.

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.

Directions

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

Children under 12 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: Consult a dentist or physician.

Other Information

Store standing up with cap tightly closed

Inactive ingredients

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

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Tube Label

THE NATURAL DENTIST  PEPPERMINT SAGE
peppermint paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0236
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL0.1 g  in 100 g
SAGE OIL (UNII: U27K0H1H2O) (SAGE - UNII:065C5D077J) SAGE OIL0.02 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
Product Characteristics
Colorwhite (Off White) Score    
ShapeSize
FlavorPEPPERMINT (Peppermint Sage) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34362-0236-1142 g in 1 TUBE; Type 0: Not a Combination Product05/01/201111/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/201111/01/2018
Labeler - Caldwell Consumer Health LLC (828558713)
Registrant - Lornamead (078584069)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead078584069manufacture(34362-0236) , pack(34362-0236)

Revised: 2/2019
 
Caldwell Consumer Health LLC