BASIL MINT WITH FLUORIDE- sodium mfp 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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Bulk - Tend Basil Mint

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

Anticavity

Aids in teh prevention of dental cavities

Keep out of reach of children under 6 years of age. If you swallow more than a pea-sized dollop, get medical help or contact a poison control center right away.

Adults and children 6 years of age and older: our dentists recommend applying a pea-sized dollop of toothpaste on a soft-bristled toothbrush. Brush teeth thoroughly for 2 minutes twice a day, and not more than 3 times a day, or as recommended by your dentist or physician. Minimize swallowing. * Children under 6 years of age: consult a dentist or physician.

glycerin, water, calcium carbonate, hydrated silica, hydroxyapatite, xanthan gum, flavor, sodium lauroyl sarcosinate, benzyl alcohol, sodium bicarbonate

Carton Example

BASIL MINT WITH FLUORIDE
sodium mfp paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62721-5058
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT (Basil Mint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62721-5058-9	96 g in 1 TUBE; Type 0: Not a Combination Product	12/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	12/31/2022

Labeler - Lornamead (126440440)

Registrant - Lornamead (080046418)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead		080046418	manufacture(62721-5058) , pack(62721-5058)

Revised: 1/2022

Document Id: d4c376d5-4215-e1ac-e053-2995a90a518b

Set id: d36ffc66-5acc-df85-e053-2a95a90a26e8

Version: 2

Effective Time: 20220104

Lornamead