Label: THERABREATH FOR KIDS ANTICAVITY WACKY WATERMELON- sodium fluoride rinse
THERABREATH FOR KIDS ANTICAVITY STRAWBERRY SPLASH- sodium fluoride rinse
THERABREATH FOR KIDS ANTICAVITY GRAPES GALORE- sodium fluoride rinse
- NDC Code(s): 10237-255-10, 10237-256-10, 10237-257-10
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated December 28, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- 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 of rinse between your teeth for 1 minute and 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 doctor.
- Other information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label - WACKY WATERMELON
- PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label - STRAWBERRY SPLASH
- PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label - GRAPES GALORE
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INGREDIENTS AND APPEARANCE
THERABREATH FOR KIDS ANTICAVITY WACKY WATERMELON
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-255 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor WATERMELON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-255-10 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/2023 THERABREATH FOR KIDS ANTICAVITY STRAWBERRY SPLASH
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-256 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-256-10 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/2023 THERABREATH FOR KIDS ANTICAVITY GRAPES GALORE
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-257 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-257-10 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/2023 Labeler - Church & Dwight Co., Inc. (001211952)