MCKESSON FLUORIDE- sodium monofluorophosphate paste, dentifrice

McKesson Fluoride by

Drug Labeling and Warnings

McKesson Fluoride by is a Otc medication manufactured, distributed, or labeled by McKesson Medical-Surgical, AmLion Toothpaste Mfg. Sdn. Bhd., AmLion. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

• Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician.
• Children under 6 years of age: Use a pea-sized amount to minimize swallowing and supervise child's brushing until good habits are established.
• Children under 2 years of age: Ask a dentist or physician.

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

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

Principal Display Panel – 1.5 oz Box Label

Mint
Flavor

McKESSON
Fluoride Toothpaste

Net Wt. 1.5 oz. (43g)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 1.5 oz Tube Label

Mint
Flavor

McKESSON
Fluoride Toothpaste

Net Wt. 1.5 oz. (43g)

INGREDIENTS AND APPEARANCE

MCKESSON FLUORIDE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0123
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0123-1	144 in 1 CARTON	02/17/2012
1		1 in 1 BOX
1		43 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68599-0123-2	144 in 1 CARTON	02/17/2012
2		1 in 1 BOX
2		78 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/17/2012

Labeler - McKesson Medical-Surgical (023904428)

Registrant - AmLion Toothpaste Mfg. Sdn. Bhd. (652244161)