Business Elite Amenity Kit

Business Elite Amenity by

Drug Labeling and Warnings

Business Elite Amenity by is a Otc medication manufactured, distributed, or labeled by Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BUSINESS ELITE AMENITY- sodium fluoride paste, dentifrice 
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.

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

BusinessEliteKit

BusinessEliteKit2

CrestCompleteToothpaste

BUSINESS ELITE AMENITY 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52460-003(NDC: 37000-020)
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALCOHOL (UNII: 3K9958V90M)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52460-003-0124 g in 1 TUBE; Type 1: Convenience Kit of Co-Package09/16/201212/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/16/201212/01/2016
Labeler - Hangzhou Zhuwen Inflight & Travel Products Co., Ltd. (421290194)
Registrant - Hangzhou Zhuwen Inflight & Travel Products Co., Ltd. (421290194)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.421290194repack(52460-003) , manufacture(52460-003)

Revised: 11/2019
 
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.