Crest Aligner Care Cavity Defense Rinse

Crest Aligner Care by

Drug Labeling and Warnings

Crest Aligner 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]

CREST ALIGNER CARE CAVITY DEFENSE RINSE- sodium fluoride rinse 
The Procter & Gamble Manufacturing Company

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Crest Aligner Care Cavity Defense Rinse

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?

1-888-399-0036

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 475 mL Bottle Label

Crest®

ALIGNER

CARE

ANTICAVITY FLUORIDE RINSE

PROTECT MY SMILE

cavity defense rinse

HELPS FORTIFY TOOTH ENAMEL

FOR PEOPLE WHO WEAR

ALIGNERS

RETAINERS

MOUTHGUARDS

FRESH MINT

IMPORTANT: Read directions for proper use.

475 mL (16 FL OZ)

CREST ALIGNER CARE  CAVITY DEFENSE RINSE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-924
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: 69423-924-16	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/02/2020	10/04/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 10/2023

Document Id: 06e54f28-7701-3b2a-e063-6294a90a7619

34390-5

Set id: c5735f28-9e23-7140-e053-2a95a90ace5b

Version: 3

Effective Time: 20231004

 

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