LORNAMEAD NATURAL WHITE- fluoride paste, dentifrice 
Lornamead

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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Natural White Extreme Sensitive Toothpaste

Drug Facts

Active ingredient

Potassium Nitrate 5% (w/w)

Sodium Fluoride 0.24% (w/w)

Purpose

Antihypersenstivity

Anticavity

Use

aids in the prevention of dental cavities

Warnings

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

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

  • 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 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

Inactive ingredients Water, Sorbiotol, Hydrated Silica, Glycerin, Cocamidopropyl Betaine, PEG-12, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Sodium Saccharin, Red 40

Store in a cool dry place. Keep tube capped when not in use.

Manufactured by:

Lornamead, Inc.

Tonawanda, NY 14150

Made in USA

Comments? Questions?

Email us at: customerservice@lornamead.com

or call 1-877-777-2743

Natural White

Extreme Sensitive

WHITENING TOOTHPASTE

TARTAR CONTROL

REDUCES SENSITIVITY

FIGHTS CAVITIES

NET WT. 4.5 OZ / 128 g

Extreme Sensitive Tartar Control Carton

LORNAMEAD  NATURAL WHITE
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-0471
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorMINT (Vanilla Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62721-0471-91 in 1 CARTON12/01/2012
1128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/01/2012
Labeler - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(62721-0471)

Revised: 12/2018
Document Id: 7e27f963-5a9c-639b-e053-2991aa0a368d
Set id: 9a1b0a11-8309-4b90-a0bc-8e6557f06959
Version: 3
Effective Time: 20181229
 
Lornamead