Label: CREST PRO-HEALTH INTENSE CLEAN MINT- cetylpyridinium chloride rinse
- NDC Code(s): 37000-479-05, 37000-479-10, 37000-479-36
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 20, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
-
Directions
- use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use
- adults and children 6 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
- do not swallow
- children 6 years to under 12 years of age: supervise use
- children under 6 years of age: do not use
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
CREST PRO-HEALTH INTENSE CLEAN MINT
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-479 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ALCOHOL (UNII: 3K9958V90M) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BENZOATE (UNII: OJ245FE5EU) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-479-05 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2018 2 NDC:37000-479-10 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2018 3 NDC:37000-479-36 36 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/01/2018 Labeler - The Procter & Gamble Manufacturing Company (004238200)