TRANSCON BUSINESS CLASS / PREMIUM ECONOMY KIT- sodium monofluorophosphate
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 Business Class / Premium Economy Kit

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of the reach of children under 6 years 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 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years : use only apea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years : ask a dentist or physician

Inactive ingredients

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call toll-free 1-800-468-6502

Package Labeling

colgate-01

TRANSCON BUSINESS CLASS / PREMIUM ECONOMY KIT
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70402-016

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70402-016-01	1 in 1 KIT; Type 0: Not a Combination Product	04/30/2018	12/31/2021

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	5 g

Part 1 of 1

COLGATE ANTICAVITY
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC:42555-060
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42555-060-94	5 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	04/30/2018	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355B	04/30/2018	12/31/2021

Labeler - Buzz Products (HK) Co. Limited (663516515)

Revised: 11/2021

Document Id: d0d9bf4e-0355-3f7d-e053-2a95a90afbb1

Set id: 4b438a86-8e00-4937-9a27-77b0dfa3a866

Version: 3

Effective Time: 20211115

Buzz Products (HK) Co. Limited