HYVEE ANTISEPTIC MINT- eucalyptol, menthol, methyl salicylate, thymol 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 INGREDIENTS

EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

PURPOSE

ANTIPLAQUE/ANTIGINGIVITIS

USES

TO HELP REDUCE AND PREVENT PLAQUE, GINGIVITIS.

WARNINGS

DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE.

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

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), ALCOHOL (21.6%), SORBITOL SOLUTION, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCARIN, SODIUM BENZOATE, GREEN 3 (CI 42053).

QUESTIONS OR COMMENTS?

1-800-289-8343

LABEL COPY

IMAGE OF THE LABEL

HYVEE  ANTISEPTIC MINT
eucalyptol, menthol, methyl salicylate, thymol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-557
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-557-341000 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(42507-557)

Revised: 9/2013
Document Id: 9cf200be-acff-4fe7-bad0-1a1cdbaadfcb
Set id: 8a7c344b-91ce-46f0-921f-a4e688cd7c90
Version: 1
Effective Time: 20130912
 
HYVEE INC.