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Antiseptic Mouth Rinse by TOPCO ASSOCIATES, LLC

Dosage form: mouthwash
Ingredients: EUCALYPTOL .092kg in 100L, MENTHOL .042kg in 100L, METHYL SALICYLATE .060kg in 100L, THYMOL .064kg in 100L
Labeler: TOPCO ASSOCIATES, LLC
NDC Code: 36800-072

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, Antiplaque

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 then 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

Other information cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰F)

Inactive ingredients water, alcohol 21.6%, sorbitol solution, flavoring, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate,  D+C yellow no. 10, FD+C green no.3

The ADA Council on Scientific Affairs Acceptance of Top Care Spring Mint Antiseptic Mouth Rinse is based on it finding that the product is effective  in helping to prevent and reduct gingivitis and plaque above the gumline, when used as directed.
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 ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
QUESTIONS? 1-888-423-0139  topcare@topco.com

Sealed With Printed Neckband For Your Protection
TopCare
SPRING MINT
Antiseptic
Mouth
Rinse
ADA
Accepted
American
Dental
Association
Kills Germs that Cause
Bad Breath,
Plaque, + the
Gum Disease
Gingivitis
COMPARE TO LISTERINE
active ingredients
1.5 LITERS (50.7 FL OZ)
ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-072
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL.042 kg  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE.060 kg  in 100 L
THYMOL (THYMOL) THYMOL.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM CITRATE 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:36800-072-861 L in 1 BOTTLE, PLASTIC
2NDC:36800-072-121.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/07/1995
Labeler - TOPCO ASSOCIATES, LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture

 
TOPCO ASSOCIATES, LLC

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Medically reviewed on Jan 1, 2018

Further information

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

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