Oral B Minute-Foam Bubble Gum

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
YOUNG DENTAL MANUFACTURING CO 1, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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
(click image for full-size original)

Product Label for Minute-Foam Mellow Mint

Mellow Mint
(click image for full-size original)

Product Label for Minute-Foam Orange-A-Tangy

oragne
(click image for full-size original)

Product Label for Minute-Foam Strawberry

strawberry
(click image for full-size original)

Product Label for Mint-Foam Grape

grape
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 12.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
POLOXAMER 407
cocamidopropyl betaine
xylitol
SUCRALOSE
SODIUM PHOSPHATE, MONOBASIC
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-0345-06 165 g in 1 BOTTLE None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 12.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
POLOXAMER 407
cocamidopropyl betaine
xylitol
SUCRALOSE
SODIUM PHOSPHATE, MONOBASIC
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-0341-06 165 g in 1 BOTTLE None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 12.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
POLOXAMER 407
cocamidopropyl betaine
xylitol
SUCRALOSE
SODIUM PHOSPHATE, MONOBASIC
Product Characteristics
Color Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-0342-06 165 g in 1 BOTTLE None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 12.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
POLOXAMER 407
cocamidopropyl betaine
xylitol
SUCRALOSE
SODIUM PHOSPHATE, MONOBASIC
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-0346-06 165 g in 1 BOTTLE None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 12.3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
POLOXAMER 407
cocamidopropyl betaine
xylitol
SUCRALOSE
SODIUM PHOSPHATE, MONOBASIC
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-0347-06 165 g in 1 BOTTLE None
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 Operations
Medical Products Laboratories, Inc 002290302 manufacture (0273-0345), manufacture (0273-0341), manufacture (0273-0342), manufacture (0273-0346), manufacture (0273-0347)

Revised: 12/2018 YOUNG DENTAL MANUFACTURING CO 1, LLC

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