American Airlilne Business Class Kit

American Airlilne Business Class Kit

Drug Labeling and Warnings

Drug Details

k">

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.

----------

American Airlilne Business Class Kit

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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask 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

image descriptionimage description

BUSINESS CLASS KIT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58701-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58701-002-101 in 1 PACKAGE05/10/2013
110 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/10/2013
Labeler - American Airlines, Inc. (006979801)

Revised: 11/2017
 
American Airlines, Inc.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.