Label: COLGATE TOTAL 12 HR PRO-SHIELD SPEARMINT SURGE- cetylpyridinium chloride rinse
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NDC Code(s):
35000-731-02,
35000-731-16,
35000-731-33,
35000-731-50, view more35000-731-84
- Packager: Colgate-Palmolive 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 11, 2023
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
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INGREDIENTS AND APPEARANCE
COLGATE TOTAL 12 HR PRO-SHIELD SPEARMINT SURGE
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-731 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 15 mg in 20 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) LEVOMENTHOL (UNII: BZ1R15MTK7) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-731-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2015 2 NDC:35000-731-84 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2015 3 NDC:35000-731-16 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2015 4 NDC:35000-731-33 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2015 5 NDC:35000-731-50 1500 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 09/01/2015 Labeler - Colgate-Palmolive Company (001344381)