Label: COLGATE KIDS UNICORN ALCOHOL FREE- sodium fluoride rinse
- NDC Code(s): 35000-334-84
- Packager: Colgate-Palmolive Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 9, 2024
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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 twice a day after brushing your teeth with a toothpaste
- vigorously swish 10 mL (2 teaspoonfuls) 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 supervison
Children under 6 years of age: consult a dentist or doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
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INGREDIENTS AND APPEARANCE
COLGATE KIDS UNICORN ALCOHOL FREE
sodium fluoride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-334 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) POLOXAMER 407 (UNII: TUF2IVW3M2) POLOXAMER 338 (UNII: F75JV2T505) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) PHOSPHORIC ACID (UNII: E4GA8884NN) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35000-334-84 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M021 01/05/2022 Labeler - Colgate-Palmolive Company (001344381)