BUSINESS CLASS KIT- sodium monofluorophosphate paste, dentifrice
American Airlines, Inc.

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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Active ingredient

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

Purpose

Anticavity

Use

helps protect against 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's brushing and rinsing (to minimize swallowing)
children under 2 years	ask a dentist or physician

Inactive 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

PRINCIPAL DISPLAY PANEL - 10g Tube Label

Label

BUSINESS CLASS KIT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58701-002
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (fluoride Ion)	fluoride Ion	7.6 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
WATER
SORBITOL
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM PYROPHOSPHATE
SACCHARIN SODIUM
LIMONENE, DL-

Packaging
#	Item Code	Package Description
1	NDC:58701-002-10	1 in 1 PACKAGE
1		10 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/10/2013

Labeler - American Airlines, Inc. (006979801)

Revised: 05/2013

Document Id: f3db8c91-0878-4263-a668-025da1bcddee

Set id: 483d7aec-34ac-49c5-ac0e-8fba5b4737ae

Version: 2

Effective Time: 20130530

American Airlines, Inc.