Description

Minute-Foam® is a flavored aqueous foaming solution of acidulated phosphate sodium fluoride with an optimized low pH and a fluoride ion

concentration of 1.23% w/w.

Inactives

Purified water
Poloxamer 407
Cocamidoprophyl betaine
Xylitol, sucralose
Sodiumphosphate monobasic
Flavor

Indication and Usage

Warnings

DO NOT SWALLOW.
Keep out of reach of children. In the event more than the treatment dose is swallowed, administer calcium (e.g.milk) and get medical help or contact a Poison Control Center right away. Avoid spraying towards open flame.
Contents under pressure. Do not puncture or incinerate. Do not expose to heat.
Store at temperatures between 59-86°F
(15-30°C). Keep from freezing.

Product Label for Minute-Foam Bubble Gum

bubble gum

Product Label for Minute-Foam Mellow Mint

Mellow Mint

Product Label for Minute-Foam Orange-A-Tangy

oragne

Product Label for Minute-Foam Strawberry

strawberry

Product Label for Mint-Foam Grape

grape

ORAL B MINUTE-FOAM BUBBLE GUM
sodium fluoride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0273-0345
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	12.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0273-0345-06	165 g in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/23/2014

ORAL B MINUTE-FOAM MELLOW MINT
sodium fluoride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0273-0341
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	12.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0273-0341-06	165 g in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/23/2014

ORAL B MINUTE-FOAM ORANGE-A-TANGY
sodium fluoride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0273-0342
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	12.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0273-0342-06	165 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	11/23/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/23/2014

ORAL B MINUTE-FOAM STRAWBERRY
sodium fluoride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0273-0346
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	12.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0273-0346-06	165 g in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/23/2014

ORAL B MINUTE-FOAM GRAPE
sodium fluoride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0273-0347
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	12.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0273-0347-06	165 g in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/23/2014	01/23/2018

Labeler - YOUNG DENTAL MANUFACTURING CO 1, LLC (006309355)

Oral B Minute-Foam Soultion