Label: CTX3 RINSE MINT- anticaries rinse
CTX3 RINSE GRAPE- anticaries rinse
CTX3 RINSE CITRUS- anticaries rinse
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Contains inactivated NDC Code(s)
NDC Code(s): 61578-301-01, 61578-301-02, 61578-302-01, 61578-303-01, view more61578-303-02 - Packager: Dental Alliance Holdings LLC
- 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 31, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients:
- Purpose:
- Use:
- Warnings:
- Warnings:
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Directions:
Adults and children 6 years of age and older: Use once daily after brushing your teeth with toothpaste. Vigorously swish 10mL of rinse between teeth for one 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: Consult a dentist or physician. Store below 30 degrees C (86 degrees F). Do not freeze.
- Inactive ingredients:
- CTx3R Mint, Citrus, and Grape enclosure labels:
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INGREDIENTS AND APPEARANCE
CTX3 RINSE MINT
anticaries rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61578-301 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 226 ug in 1 mL Inactive Ingredients Ingredient Name Strength MENTHOL (UNII: L7T10EIP3A) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color white (opaque) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61578-301-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2012 09/30/2022 2 NDC:61578-301-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2012 09/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/01/2012 09/30/2022 CTX3 RINSE GRAPE
anticaries rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61578-303 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 226 ug in 1 mL Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color white (opaque) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61578-303-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2012 2 NDC:61578-303-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2012 11/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/01/2012 CTX3 RINSE CITRUS
anticaries rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61578-302 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 226 ug in 1 mL Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color white (opaque) Score Shape Size Flavor CITRUS Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61578-302-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/01/2012 Labeler - Dental Alliance Holdings LLC (195544965) Registrant - Dental Alliance Holdings LLC (195544965) Establishment Name Address ID/FEI Business Operations Dental Alliance Holdings LLC 195544965 manufacture(61578-301, 61578-302, 61578-303)