Label: COLGATE GREAT REGULAR FLAVOR- sodium monofluorophosphate paste, dentifrice
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NDC Code(s):
35000-913-01,
35000-913-04,
35000-913-20,
35000-913-33, view more35000-913-46, 35000-913-48, 35000-913-58, 35000-913-60, 35000-913-64, 35000-913-69, 35000-913-79, 35000-913-82, 35000-913-92, 35000-913-93
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
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 December 3, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
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INGREDIENTS AND APPEARANCE
COLGATE GREAT REGULAR FLAVOR
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-913 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.0 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM LAURYL SULFATE (UNII: 368GB5141J) 49.14 mg in 1 g WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-913-20 24 g in 1 TUBE; Type 0: Not a Combination Product 11/05/2005 2 NDC:35000-913-33 1 in 1 CARTON 11/05/2005 2 36.8 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:35000-913-69 1 in 1 CARTON 11/05/2005 3 113 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:35000-913-46 1 in 1 CARTON 11/05/2005 4 130 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:35000-913-60 170 g in 1 TUBE; Type 0: Not a Combination Product 11/05/2005 6 NDC:35000-913-64 1 in 1 CARTON 11/05/2005 6 181 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:35000-913-82 1 in 1 CARTON 11/05/2005 7 232 g in 1 TUBE; Type 0: Not a Combination Product 8 NDC:35000-913-04 4.25 g in 1 POUCH; Type 0: Not a Combination Product 11/05/2005 9 NDC:35000-913-79 1 in 1 CARTON 11/05/2005 9 79 g in 1 TUBE; Type 0: Not a Combination Product 10 NDC:35000-913-93 99 g in 1 TUBE; Type 0: Not a Combination Product 11/05/2005 11 NDC:35000-913-48 1 in 1 CARTON 11/05/2005 11 226 g in 1 TUBE; Type 0: Not a Combination Product 12 NDC:35000-913-01 1 in 1 CARTON 11/05/2005 12 28 g in 1 TUBE; Type 0: Not a Combination Product 13 NDC:35000-913-58 1 in 1 CARTON 11/05/2005 13 70 g in 1 TUBE; Type 0: Not a Combination Product 14 NDC:35000-913-92 1 in 1 CARTON 11/05/2005 14 141 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 11/05/2005 Labeler - Colgate-Palmolive Company (001344381)