ANTISPETIC- eucalyptol, menthol, methyl salicylate and thymol mouthwash 
DZA Brands LLC

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

Active ingredients

Eucalyptol 0.0692%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Purpose

Antigingivitis, antiplaque

Use

Use help control plaque that leads to gingivitis

Warnings

Warnings

Do not use

Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Stop use

Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

Keep out of reach of children.

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

children unmder 12 years of age - consult a dentist or doctor

Other information

Other informationcold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F)

Inactive ingredients

Inactive ingredients water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD+C green no.3

Disclaimer

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine

Adverse Reactions

Distributed by: DZA Brands, LLC

2110 Executive Drive

Salisbury, NC 28147

For product questions or concerns contact us at 1-866-322-2439. Please include UPC number and code from package

Principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

healthy

accents

blue mint

antiseptic

mouth rinse

kills germs that cause bad breath,

plaque + the gum disease gingivitis

compare to the active

ingredients of Listerine

500 mL (16.9 FL OZ)

image description

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-664
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 0.64 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:55316-664-77 500 mL in 1 BOTTLE, PLASTIC
2 NDC:55316-664-86 1000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 02/05/2008
Labeler - DZA Brands LLC (090322194)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(55316-664)

Revised: 2/2013
Document Id: 570deb8f-07bd-4f53-b0c6-9e12f739a28f
Set id: 163f8279-30ed-4f79-a391-45df95584ed3
Version: 1
Effective Time: 20130227
 
DZA Brands LLC