ORAL B MINUTE-FOAM BUBBLE GUM- sodium fluoride solution ORAL B MINUTE-FOAM MELLOW MINT- sodium fluoride solution ORAL B MINUTE-FOAM ORANGE-A-TANGY- sodium fluoride solution ORAL B MINUTE-FOAM STRAWBERRY- sodium fluoride solution ORAL B MINUTE-FOAM GRAPE- sodium fluoride solution

Oral B Minute-Foam by

Drug Labeling and Warnings

Oral B Minute-Foam by is a Prescription medication manufactured, distributed, or labeled by YOUNG DENTAL MANUFACTURING CO 1, LLC, Medical Products Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Label for Minute-Foam Mellow Mint

Product Label for Minute-Foam Orange-A-Tangy

Product Label for Minute-Foam Strawberry

Product Label for Mint-Foam Grape

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc		002290302	manufacture(0273-0345, 0273-0341, 0273-0342, 0273-0346, 0273-0347)