HEMP WITH FLOURIDE, SPEARMINT- sodium monofluorophosphate 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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8015030 Hemp with Fluoride, Spearmint

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion) . . . Anticavity

aids in the prevention of dental cavities

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 of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor. * instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). * supervise children as necessary until capable of using without supervision. * children under 2 years of age: Consult a dentist or doctor.

Tamper evident, use only if box seal is intact. Keep tube capped when not in use. When using this product, if irritation occurs, discontinue use. Keep out of reach of children.

glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, cannabis sativa (hemp) seed oil, sodium sauroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol

Sample Artwork

HEMP WITH FLOURIDE, SPEARMINT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-0030
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
ZINC CITRATE (UNII: K72I3DEX9B)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
XYLITOL (UNII: VCQ006KQ1E)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Product Characteristics
Colorwhite (Off white) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62721-0030-9156 g in 1 TUBE; Type 0: Not a Combination Product06/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/19/2020
Labeler - Lornamead (126440440)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(62721-0030)

Revised: 6/2020
Document Id: a87144c8-0cea-5abb-e053-2a95a90a9873
Set id: a87144c8-0ce9-5abb-e053-2a95a90a9873
Version: 1
Effective Time: 20200619
 
Lornamead