Label: CREST PRO-HEALTH ADVANCED W/EXTRA DEEP CLEAN- sodium fluoride rinse
- NDC Code(s): 37000-865-01, 37000-865-02, 37000-865-36
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 19, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warning
-
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.
- Adults and children 6 years & older:
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
ALCOHOL FREE
WITH FLUORIDECrest ®
PRO-HEALTH™
ADVANCED
ANTICAVITY FLUORIDE MOUTHWASHSTRONGER TEETH*
FOR A HEALTHIER MOUTHWITH
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 rinseProduct 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)