Label: COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE- sodium fluoride rinse
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Contains inactivated NDC Code(s)
NDC Code(s): 67659-034-30 - Packager: Team Technologies, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0126-0034
- 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 December 26, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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
IDEAL 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 ®P9895933
Phos Flur Artwork
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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:67659-034(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, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) 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:67659-034-30 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 08/01/2017 Labeler - Team Technologies, Inc. (192339703) Registrant - Team Technologies, Inc. (192339703) Establishment Name Address ID/FEI Business Operations Team Technologies, Inc 079337800 repack(67659-034) , relabel(67659-034)