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Business Elite Amenity

Medically reviewed on December 30, 2017

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 1.5mg in 1g
Labeler: Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.
NDC Code: 52460-003

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.

Business Elite Amenity Kit

Business Elite Amenity Kit

Active Ingredient

Sodium fluoride 0.243%

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 yrs. 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 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

sorbitol, water, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol (0.7%), xanthan gum, sodium saccharin, glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

Questions?

1-800-492-7378

Dist. by Procter & Gamble,
Cincinnati, OH 45202

Business Elite Amenity Kit



BUSINESS ELITE AMENITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52460-003(NDC:37000-020)
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
SODIUM ACID PYROPHOSPHATE 
SODIUM LAURYL SULFATE 
SODIUM HYDROXIDE 
ALCOHOL 
XANTHAN GUM 
SACCHARIN SODIUM (SACCHARIN)  
GLYCERIN 
CARBOXYMETHYLCELLULOSE SODIUM 
POLYSORBATE 80 
SODIUM BENZOATE 
CETYLPYRIDINIUM CHLORIDE 
BENZOIC ACID 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52460-003-0124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/16/2012
Labeler - Hangzhou Zhuwen Inflight & Travel Products Co., Ltd. (421290194)
Registrant - Hangzhou Zhuwen Inflight & Travel Products Co., Ltd. (421290194)
Establishment
NameAddressID/FEIOperations
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.421290194repack(52460-003), manufacture(52460-003)

 
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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