Label: HYVEE COMPLETE CARE FRESH MINT- sodium fluoride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 42507-552-33 - 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 27, 2015
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INGREDIENTS AND APPEARANCE
HYVEE COMPLETE CARE FRESH MINT
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-552 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) ALCOHOL (UNII: 3K9958V90M) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM LAURYL SULFATE (UNII: 368GB5141J) EUCALYPTOL (UNII: RV6J6604TK) METHYL SALICYLATE (UNII: LAV5U5022Y) THYMOL (UNII: 3J50XA376E) PHOSPHORIC ACID (UNII: E4GA8884NN) SUCRALOSE (UNII: 96K6UQ3ZD4) MENTHOL (UNII: L7T10EIP3A) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42507-552-33 1000 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 09/12/2013 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(42507-552)