Label: TOMS CHILDRENS ANTICAVITY MOUTHWASH SILLY STRAWBERRY- sodium fluoride rinse
- NDC Code(s): 51009-840-52
- Packager: Tom's of Maine, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 18, 2024
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 10mL)
- Purpose
- Use
- Warnings
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Directions
Adults and children 6 years of age and older:
- use twice 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
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Inactive ingredients
water, glycerin, Aloe barbadensis leaf juice1, xylitol, sodium phosphate, propanediol, benzoic acid, natural flavor, phosphoric acid, menthol, Fragaria ananassa (Strawberry) fruit juice, Ananas sativus (Pineapple) fruit juice, Citrus aurantium dulcis (Orange) juice, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Rebaudioside A
- 1
- organic
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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INGREDIENTS AND APPEARANCE
TOMS CHILDRENS ANTICAVITY MOUTHWASH SILLY STRAWBERRY
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-840 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) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) XYLITOL (UNII: VCQ006KQ1E) SODIUM PHOSPHATE (UNII: SE337SVY37) BENZOIC ACID (UNII: 8SKN0B0MIM) ALOE VERA LEAF (UNII: ZY81Z83H0X) LEVOMENTHOL (UNII: BZ1R15MTK7) PHOSPHORIC ACID (UNII: E4GA8884NN) STRAWBERRY JUICE (UNII: U8NS58UGW0) PINEAPPLE JUICE (UNII: O4KOG0B1KC) ORANGE JUICE (UNII: 5A9KE2L9L3) LEMON JUICE (UNII: AGN709ANTJ) MANGO JUICE (UNII: IU6I1JNV24) REBAUDIOSIDE A (UNII: B3FUD0528F) Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-840-52 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M021 12/18/2018 Labeler - Tom's of Maine, Inc. (052764354)
