Label: HYVEE ANTICAVITY MINT- sodium fluoride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 42507-554-17 - Packager: HYVEE INC.
- 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 November 30, 2015
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- Active ingredient
- Uses
- Warnings
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Directions
- Adults and children 6 years of age and older:
- use once a day after brushing your teeth with toothpaste
- vigorously swish 10 mL 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
- 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
- Questions or comments?
- Label Copy
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INGREDIENTS AND APPEARANCE
HYVEE ANTICAVITY MINT
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-554 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) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE (UNII: SE337SVY37) POLYSORBATE 20 (UNII: 7T1F30V5YH) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) MENTHOL (UNII: L7T10EIP3A) METHYL SALICYLATE (UNII: LAV5U5022Y) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42507-554-17 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/29/2015 Labeler - HYVEE INC. (006925671) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(42507-554)