HYVEE PRO CLEAN BLUE MINT- cetylpyridinium chloride 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

CETYLPYRIDINIUM CHLORIDE

PURPOSE

ANTIGINGIVITIS/ANTIPLAQUE

USES

HELPS REDUCE AND PREVENT PLAQUE AND GINGIVITIS. HELPS CONTROL PLAQUE BACTERIA THAT CONTRIBUTE TO THE DEVELOPMENT OF GINGIVITIS AND BLEEDING GUMS.

WARNINGS

ASK A DENTIST IF SYMPTOMS PERSIST OR CONDITION WORSENS AFTER REGULAR USE. 

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.

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

DIRECTIONS

USE AFTER YOUR NORMAL BRUSHING AND FLOSSING ROUTINE; RINSE TOOTHPASTE FROM MOUTH PRIOR TO USE. ADULTS AND CHILDREN 6 YEARS AND OLDER: RINSE FOR 30 SECONDS WITH 20 ML (4 TEASPOONFULS) TWICE A DAY. DO NOT SWALLOW. CHILDREN 6 YEARS TO UNDER 12 YEARS OF AGE: SUPERVISE USE. CHILDREN UNDER 6 YEARS OF AGE: DO NOT USE. 

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

WATER (AQUA), GLYCERIN, POLOXAMER 407, FLAVOR, SODIUM SACCHARIN, METHYLPARABEN, SUCRALOSE, PROPYLPARABEN, BLUE 1 (CI 42090).

QUESTIONS OR COMMENTS?

1-800-289-8343

LABEL COPY

IMAGE OF THE LABEL

HYVEE  PRO CLEAN BLUE MINT
cetylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-553
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-553-16474 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/12/2013
Labeler - HYVEE INC. (006925671)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(42507-553)

Revised: 9/2013
Document Id: 8266845c-3393-4789-a189-481cbeb228d6
Set id: 76b1059b-abc5-44b0-92f4-fada3573ae9a
Version: 1
Effective Time: 20130912
 
HYVEE INC.