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Antiseptic Mouth Rinse by Topco Associates LLC

Medically reviewed on Apr 2, 2018

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.092kg in 100L, MENTHOL 0.042kg in 100L, METHYL SALICYLATE 0.060kg in 100L, THYMOL 0.064kg in 100L
Labeler: Topco Associates LLC
NDC Code: 36800-210

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
Antigingivitis

Use helps control plaque that leads to gingivitis

Warnings

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

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 
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 the spit out; do not swallow
children under 12 years of age - consult a dentist or doctor
• this rinse is not intended to replace brushing or flossing

Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40

This product is not manufactured or distributed by Johnson+Johnson HealthCare Products, distributor of Listerine
DSP-TN-15000
DSP-MO-34
SDS-TN-15012

DISTRIBUTED BY TOPCO ASSOCIATED, LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
QUESTIONS 1-800-423-0139
topcare@topco.com

TopCare
CITRUS
Antiseptic
Mouth Rinse
Control Tartar
Kills Germs for Extended
Plaque Protection
Helps Fight Tartar Buildup
Fights Plaque and Gingivitis
Enhanced Breath Protection
COMPARE TO CITRUS ADVANCED
LISTERINE with tartar protection
Sealed With Printed Neckband For Your Protection
16.9 FL OZ (1.05 PT) 500 mL
ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL0.042 kg  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE0.060 kg  in 100 L
THYMOL (THYMOL) THYMOL0.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
POLOXAMER 407 
BENZOIC ACID 
ZINC CHLORIDE 
SUCRALOSE 
SODIUM BENZOATE 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
Packaging
#Item CodePackage Description
1NDC:36800-210-861.0 L in 1 BOTTLE, PLASTIC
2NDC:36800-210-121.5 L in 1 BOTTLE, PLASTIC
3NDC:36800-210-770.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/20/1992
Labeler - Topco Associates LLC (006935977)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture

 
Topco Associates LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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