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.

----------

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 RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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

STORE AT ROOM TEMPERATURE. COLD WEATHER MAY CLOUD THIS PRODUCT. ITS ANTISEPTIC PROPERTIES ARE NOT AFFECTED.

INACTIVE INGREDIENTS:

WATER, SORBITOL, PROPYLENE GLYCOL, SODIUM PHOSPHATE, POLYSORBATE 20, FLAVOR, POLOXAMER 407, SODIUM BENZOATE, POTASSIUM SORBATE, CALICUM DISODIUM EDTA, DISODIUM PHOSPHATE, SODIUM SACCHARIN, CETYLPYRIDINIUM CHLORIDE, MENTHOL, METHYL SALICYLATE, GREEN 3 (CI 42053), 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42507-554
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE 
POLYSORBATE 20 
POLOXAMER 407 
SODIUM BENZOATE 
POTASSIUM SORBATE 
EDETATE CALCIUM DISODIUM ANHYDROUS 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
SACCHARIN SODIUM 
CETYLPYRIDINIUM CHLORIDE 
MENTHOL 
METHYL SALICYLATE 
FD&C GREEN NO. 3 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-554-16474 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/12/2013
Labeler - HYVEE INC. (006925671)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(42507-554)

Revised: 9/2013
Document Id: 833558d7-a048-4e19-b08f-1a1c7d58512a
Set id: 8cca3d39-1df2-4e83-af2b-1f6599dfb27b
Version: 1
Effective Time: 20130912
 
HYVEE INC.