AMERICAN AIRLINES INTERNATIONAL BUSINESS- 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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American Airlines International Business 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 a pea 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 to-free 1-800-468-6502

American Airlines International Business Kit (70402-020-00)

Kit

Component: Colgate, 10g (70402-021-00)

Label Tube Tube2

AMERICAN AIRLINES INTERNATIONAL BUSINESS
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70402-020

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70402-020-00	1 in 1 KIT	07/01/2018	12/31/2021

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	10 g

Part 1 of 1

COLGATE
sodium monofluorophosphate paste

Product Information
Item Code (Source)	NDC:70402-021
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)

#	Item Code	Package Description
Packaging
1	NDC:70402-021-00	1 in 1 CARTON
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355B	07/01/2018	12/31/2021

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

Revised: 11/2021

Document Id: d09c2f55-419c-9154-e053-2995a90a63c1

Set id: b54d4597-7448-4af7-a6a4-c6d3968396b3

Version: 6

Effective Time: 20211112

Buzz Products (HK) Co. Limited