HYVEE ANTISEPTIC ORIGINAL- 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.

----------

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 in 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

Other information

Inactive ingredients

Water (Aqua), Alcohol (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

Questions or comments?

1-800-289-8343

Label Copy

Image of the label

HYVEE  ANTISEPTIC ORIGINAL
eucalyptol, menthol, methyl salicylate, thymol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-556
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)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-556-501500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/02/2016
Labeler - HYVEE INC (006925671)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(42507-556)

Revised: 3/2016
Document Id: 96112b5f-5b0b-42f5-bf80-6ff42d267dc7
Set id: 1bc78b29-cc1c-4a2e-9d5f-ad8395b399e4
Version: 2
Effective Time: 20160303
 
HYVEE INC