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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52460-003(NDC:37000-020)
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	green	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52460-003-01	24 g in 1 TUBE; Type 1: Convenience Kit of Co-Package	09/16/2012	12/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/16/2012	12/01/2016

Labeler - Hangzhou Zhuwen Inflight & Travel Products Co., Ltd. (421290194)

Registrant - Hangzhou Zhuwen Inflight & Travel Products Co., Ltd. (421290194)

Name	Address	ID/FEI	Business Operations
Establishment
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.		421290194	repack(52460-003) , manufacture(52460-003)

Revised: 11/2019

Document Id: 97284f6e-b28f-fe4c-e053-2995a90afe80

Set id: 70fe7359-51da-41ac-a013-968626a707fe

Version: 4

Effective Time: 20191112

Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.