Business Elite Amenity Kit

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.
INN (International Name):
SODIUM FLUORIDE
Composition:
FLUORIDE ION 1.5 mg in 1 g
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anticavity toothpaste helps protect against cavities
Authorization status:
OTC monograph final
Authorization number:
52460-003-01

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.

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Business Elite Amenity Kit

Business Elite Amenity Kit

Active Ingredient

Sodium fluoride 0.243%

Purpos e

Anticavity toothpaste

Us e

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

Ques tions ?

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5246 0 -0 0 3(NDC:370 0 0 -0 20 )

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

1.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

SO RBITO L (UNII: 50 6 T6 0 A25R)

WATER (UNII: 0 59 QF0 KO0 R)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

SO DIUM ACID PYRO PHO SPHATE (UNII: H5WVD9 LZUD)

Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

XANTHAN GUM (UNII: TTV12P4NEE)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

GLYCERIN (UNII: PDC6 A3C0 OX)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P)

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

Product Characteristics

Color

gre e n

S core

S hap e

S iz e

Flavor

PEPPERMINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5246 0 -0 0 3-0 1

24 g in 1 TUBE; Type 1: Co nvenience Kit o f Co -Package

0 9 /16 /20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 9 /16 /20 12

Labeler -

Hangzhou Zhuwen Inflight & T ravel Products Co., Ltd. (421290194)

Registrant -

Hangzhou Zhuwen Inflight & T ravel Products Co., Ltd. (421290194)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hangzho u Zhuwen Inflight & Travel Pro ducts Co ., Ltd.

42129 0 19 4

repack(5246 0 -0 0 3) , manufacture(5246 0 -0 0 3)

Revised: 9/2019

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