Label: COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE- sodium fluoride rinse
- NDC Code(s): 0126-0034-46
- Packager: Colgate Oral Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 12, 2024
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
adults and children 6 years of age and older - use once a day after brushing your teeth with a toothpaste
- vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute 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 - ask a dentist or physician
- Inactive ingredients
- Other Information
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
ALCOHOL FREE*
Colgate®
Phos•Flur®
Ortho Defense®
Anticavity Fluoride Rinse
Sodium Fluoride Acidulated Phosphate SolutionIDEAL PROTECTION
WHILE WEARING BRACES- ✓
- ORTHODONTIST RECOMMENDED
- ✓
- HELPS STRENGTHEN ENAMEL
- ✓
- HELPS PREVENT CAVITIES
GUSHING GRAPE
16.9 FL OZ (1.05 PT) 500 mL
IMPORTANT: Read directions for proper use
ADA
Accepted
American
Dental
Association ®P9910320
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INGREDIENTS AND APPEARANCE
COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0126-0034 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2 mg in 10 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SODIUM PHOSPHATE (UNII: SE337SVY37) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHOSPHORIC ACID (UNII: E4GA8884NN) POLYSORBATE 20 (UNII: 7T1F30V5YH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0126-0034-46 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M021 02/15/2011 Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118) Registrant - Colgate-Palmolive Company (001344381)