OTC Medication Information: Antiseptic Mouth Rinse

ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate and thymol mouthwash
TOPCO ASSOCIATES, 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.

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

for this product

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

claims

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

Adverse reaction

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com

The Top Care product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

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COMPARE TO LISTERINE

TopCare

everyday

Antiseptic

Mouthwash

ANTIGINGIVITIS/ANTIPLAQUE

SPRING MINT

  • For better oral hygiene & fresher breath
  • Kills germs that cause bad breath, plaque & the gum disease gingivitis

ADA

Accepted

American

Dental Association

  • Helps reduce plaque
  • Helps reduce gingivitis

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

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ANTISEPTIC MOUTH RINSE
eucalyptol, menthol, methyol salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-072
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg in 1 mL
MENTHOL (MENTHOL) MENTHOL 0.42 mg in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.60 mg in 1 mL
THYMOL (THYMOL) THYMOL 0.64 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
POLOXAMER 407
BENZOIC ACID
SACCHARIN SODIUM
SODIUM CITRATE
D&C YELLOW NO. 10
FD&C GREEN NO. 3
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-072-86 1000 mL in 1 BOTTLE, PLASTIC None
2 NDC:36800-072-12 1500 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/07/1995
Labeler — TOPCO ASSOCIATES, LLC (006935977)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (36800-072)

Revised: 03/2021 TOPCO ASSOCIATES, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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