HYVEE ANTICAVITY MINT- sodium fluoride liquid 
HYVEE INC.

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.

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DRUG FACTS

Active ingredient

Sodium Fluoride 0.05% (0.02% w/v Fluoride ion)

Purpose

Antigingivitis/Antiplaque

Uses

aids in the prevention of dental cavities

Warnings

Keep out of reach of children

Keep out of reach of children.

If more than used for rinsin is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

Calcium Disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Green 3 (CI 42053), Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water (Aqua), Yellow 5 (CI 19140).

Questions or comments?

1-800-289-8343

Label Copy

Image of the label

HYVEE  ANTICAVITY MINT
sodium fluoride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-554
Route of Administration ORAL DEA Schedule     
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)

Revised: 11/2015
Document Id: 6ad57f6e-a256-4f25-9206-cf0822da1a50
Set id: 8cca3d39-1df2-4e83-af2b-1f6599dfb27b
Version: 2
Effective Time: 20151130
 
HYVEE INC.