CREST PRO-HEALTH ADVANCED W/EXTRA DEEP CLEAN- sodium fluoride rinse

Crest Pro-Health by

Drug Labeling and Warnings

Crest Pro-Health by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company, Procter & Gamble Manufacturing Company (Iowa City). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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 (2 teaspoonfuls) 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

water, glycerin, flavor, poloxamer 407, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, sucralose, propylparaben, disodium phosphate, red 33, green 3

Questions?

1-800-285-9139

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DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ALCOHOL FREE

WITH FLUORIDE

Crest ®

PRO-HEALTH™

ADVANCED

ANTICAVITY FLUORIDE MOUTHWASH

STRONGER TEETH*

FOR A HEALTHIER MOUTH

WITH

EXTRA DEEP CLEAN**

IMPORTANT:

Read directions

for proper use.

+ KILLS BAD BREATH GERMS

+ HELPS PREVENT CAVITIES

+ STRENGTHENS ENAMEL

+ CLEANS TEETH & GUMS

+ FRESHENS BREATH

500 mL

(16.9 FL OZ)

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  ADVANCED W/EXTRA DEEP CLEAN
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-865
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)
GLYCERIN (UNII: PDC6A3C0OX)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
METHYLPARABEN (UNII: A2I8C7HI9T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-865-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2016
2	NDC: 37000-865-02	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2016
3	NDC: 37000-865-36	36 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/20/2015

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
Procter & Gamble Manufacturing Company (Iowa City)		005279245	manufacture(37000-865)