NATURAL ADULT FLUORIDE- sodium monofluorophosphate paste 
Kroger

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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5820023 Natural Adult Fluoride

Active ingredient Purpose

Sodium monofluorophosphate 0/76% (0.13% w/v fluoride ion) . . . Anticavity

Uses

aids in the prevention of dental cavities

Keep out of reach of children under 6 years of age. If more than is swallowed for brushing si 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.

glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, sodium lauroyl sarcosinate, flavor, zinc citrate, benzyl alcohol

Carton Artwork

NATURAL ADULT FLUORIDE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-223
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
CARRAGEENAN (UNII: 5C69YCD2YJ)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
ZINC CITRATE (UNII: K72I3DEX9B)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Product Characteristics
Colorwhite (Off white) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-223-391 in 1 CARTON06/02/2020
1155.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/02/2020
Labeler - Kroger (006999528)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(30142-223)

Revised: 1/2023
Document Id: f21502e4-736b-05c7-e053-2a95a90a9336
Set id: a71c537e-39d9-1c3b-e053-2a95a90ac3ec
Version: 2
Effective Time: 20230112
 
Kroger