HYVEE COMPLETE CARE FRESH 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 0.02% (0.01% W/V FLUORIDE ION)

PURPOSE

ANTIGINGIVITIS/ANTIPLAQUE

USES

TO HELP REDUCE AND PREVENT PLAQUE, GINGIVITIS.

WARNINGS

DO NOT USE IN CHILDREN UNDER 12 YEARS OF AGE.

KEEP OUT OF REACH OF CHILDREN.

IF MORE THAN USED FOR RINSING IS ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

RINSE FULL STRENGTH FOR 30 SECONDS WITH 20 ML (2/3 FLUID OUNCE OR 4 TEASPOONFULS) MORNING AND NIGHT. DO NOT SWALLOW.

OTHER INFORMATION

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

INACTIVE INGREDIENTS:

WATER (AQUA), SORBITOL, ALCOHOL (21.6%), POLOXAMER 407, SODIUM LAURYL SULFATE, EUCALYPTOL, FLAVOR, METHYL SALICYLATE, THYMOL, PHOSPHORIC ACID, SUCRALOSE, MENTHOL, DISODIUM PHOSPHATE, RED 40 (CI 16035), BLUE 1 (ci 42090).

QUESTIONS OR COMMENTS?

1-800-289-8343

LABEL COPY

IMAGE OF THE LABEL

HYVEE  COMPLETE CARE FRESH MINT
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42507-552
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
ALCOHOL 
POLOXAMER 407 
SODIUM LAURYL SULFATE 
EUCALYPTOL 
METHYL SALICYLATE 
THYMOL 
PHOSPHORIC ACID 
SUCRALOSE 
MENTHOL 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-552-341000 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(42507-552)

Revised: 9/2013
Document Id: 89c33d7c-9a32-4369-ae42-40470b9b103a
Set id: 06c7ee9c-f8d6-4039-add9-193ea44f2b6d
Version: 1
Effective Time: 20130912
 
HYVEE INC.