TRANSCON FIRST AMENITY KIT- sodium fluoride paste, dentifrice
BUZZ PRODUCTS (HK) CO. LIMITED

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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Transcon First Amenity Kit

Drug Facts

Active Ingredients

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect teeth and roots 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, sodium lauryl sulfate, trisodium phosphate, flavor, sodium phosphate, cellulose gum, carbomer 956, sodium saccharin, titanium dioxide, blue 1

Questions?

1-800-492-7378

Package Label

Toothpaste

TRANSCON FIRST AMENITY KIT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70402-006
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 LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70402-006-01	24 g in 1 TUBE; Type 1: Convenience Kit of Co-Package	02/01/2016	12/18/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	02/01/2016	12/18/2018

Labeler - BUZZ PRODUCTS (HK) CO. LIMITED (663516515)

Revised: 12/2018

Document Id: 7d4eeb55-ae27-26e4-e053-2991aa0a5a14

Set id: 513dbebd-d5d7-4b9a-8bb9-65febcd75892

Version: 4

Effective Time: 20181218

BUZZ PRODUCTS (HK) CO. LIMITED