MCKESSON FLUORIDE- sodium monofluorophosphate paste, dentifrice 
McKesson Medical-Surgical

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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68599-0123

Drug Facts

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.122% w/v of fluoride ion)

Purpose

Anticavity

Use

Helps protect against cavities.

Warnings

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Directions

Inactive ingredients

calcium carbonate, purified water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxy methyl cellulose, sodium benzoate, sodium saccharin

Principal Display Panel – 1.5 oz Case Label

Mint
Flavor

McKESSON
Fluoride Toothpaste

1 Tube per Box, 1.5 oz
144 Boxes Per Case

Reorder No. 16-9571

Principal Display Panel – 1.5 oz Case Label

Principal Display Panel – 1.5 oz Box Label

Mint
Flavor

McKESSON
Fluoride Toothpaste

Net Wt. 1.5 oz. (43g)

Principal Display Panel – 1.5 oz Box Label

Principal Display Panel – 1.5 oz Tube Label

Mint
Flavor

McKESSON
Fluoride Toothpaste

Net Wt. 1.5 oz. (43g)

Principal Display Panel – 1.5 oz Tube Label
MCKESSON FLUORIDE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0123
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-0123-1144 in 1 CARTON02/17/201206/01/2026
11 in 1 BOX
143 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68599-0123-2144 in 1 CARTON02/17/201206/01/2026
21 in 1 BOX
278 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/17/201206/01/2026
Labeler - McKesson Medical-Surgical (023904428)
Registrant - AmLion Toothpaste Mfg. Sdn. Bhd. (652244161)
Establishment
NameAddressID/FEIBusiness Operations
AmLion652244161manufacture(68599-0123)

Revised: 2/2024
Document Id: 126211cb-7a4f-ab91-e063-6294a90a7431
Set id: 40057da9-2a4e-4bae-b5b4-606e9b757dc7
Version: 7
Effective Time: 20240227
 
McKesson Medical-Surgical