Label: COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY MINT FLUORIDE- sodium fluoride rinse
- NDC Code(s): 0126-0032-46
- Packager: Colgate Oral Pharmaceuticals, Inc.
- 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 August 5, 2022
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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®
Anticavity Fluoride RinseOrtho
Defense®Phos • Flur®
Sodium Fluoride Acidulated
Phosphate SolutionIDEAL PROTECTION
WHILE WEARING BRACES- ✓
- ORTHODONTIST RECOMMENDED
- ✓
- HELPS STRENGTHEN ENAMEL
- ✓
- HELPS PREVENT CAVITIES
16.9 FL OZ
(1.05 PT)
500 mLMINT
ADA
Accepted
American
Dental
Association ®IMPORTANT: Read
directions for proper useP9933378
Protection between Brushings
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INGREDIENTS AND APPEARANCE
COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY MINT FLUORIDE
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0126-0032 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) POLOXAMER 338 (UNII: F75JV2T505) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHOSPHORIC ACID (UNII: E4GA8884NN) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0126-0032-46 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/12/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 01/12/2011 Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)