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 AND 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 SECONS 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, FLAVOR, POLOXAMER 407, BENZOIC ACID, SODIUM SACCHARIN, SODIUM BENZOATE, YELLOW 10 (CI 47005), 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:42507-158
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)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-158-511500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/21/2014
Labeler - HYVEE INC (006925671)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(42507-158)

Revised: 3/2014
Document Id: e2f1e730-f3f1-4143-ab68-1f4d42406718
Set id: 61c60f75-9bb8-47de-aac2-8df4ff9e822a
Version: 1
Effective Time: 20140324
 
HYVEE INC