CREST BRACES CARE ANTICAVITY FLUORIDE RINSE- sodium fluoride rinse

Crest Braces Care by

Drug Labeling and Warnings

Crest Braces Care by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warning

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 6 years & older:
  • Use twice a day after brushing your teeth with a toothpaste.
  • Vigorously swish 10 mL of rinse between your teeth for 1 minute and then spit out.
  • Do not swallow the rinse.
  • Do not eat or drink for 30 minutes after rinsing.
  • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
• Children under 6 years of age: consult a dentist or doctor.

Inactive ingredients

benzoic acid, disodium phosphate, flavor, phosphoric acid, poloxamer 407, polysorbate 80, propylene glycol, sodium benzoate, sucralose, water

Questions?

1-844-436-7026

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 475 mL Bottle Label

Crest®

BRACES

CARE™

ANTICAVITY FLUORIDE RINSE

mouthwash

HELPS PROTECT AGAINST

ENAMEL LOSS TO FIGHT CAVITIES

FOR PEOPLE WHO

WEAR BRACES

AGES 6+

FRESH MINT

475 mL (16 FL OZ)

INGREDIENTS AND APPEARANCE

CREST BRACES CARE  ANTICAVITY FLUORIDE RINSE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-881
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-881-16	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/01/2022

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
THE PROCTER & GAMBLE MANUFACTURING COMPANY		005279245	manufacture(69423-881)