MURCHISON HUME DENTAL KIT- sodium monofluorophosphate
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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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Murchison-Hume Dental Kit Toothbrush and Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Indication

Aids in the prevention of dental cavities

Warnings

Keep out of the 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 a day, or as directed by a dentist or physician
children 2 to 6 years	use only a pea sized amount and supervise child brushing and rinsing (Do not swallow)
children under 2 years	ask a dentist or physician

Non medicinal ingredients

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call toll-free 1-800-468-6502

Package Labeling:Kit

Kit

Package Labeling:69491-033-01

Label Label2 Brush

MURCHISON HUME DENTAL KIT
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69491-034

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69491-034-01	1 in 1 KIT	10/15/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	10 g

Part 1 of 1

COLGATE ANTICAVITY
sodium monofluorophosphate paste

Product Information
Item Code (Source)	NDC:69491-033
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69491-033-01	10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/15/2020

Labeler - Buzz Export Services Pty., Ltd. (747317902)