OTC Medication Information: Antispetic

ANTISPETIC- 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 0.0692%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

help 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

Inactive ingredients

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

ADA Council Statement

The ADA council on Scientific Affairs Acceptance of CVS/pharmacy Blue Mint Antiseptic Mouthwash is based on its finding that the product is effectie in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

Disclaimer

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

Adverse Reactions

DIST BY TOPCO ASSOCIATES LLC

7711 GROSS PROINT ROAD

SKOKIE, IL 60077

QUESTIONS? 1-888-423-0139

topcare@topco.com

664.002/664AS

Principal Display Panel

COMPARE TO LISTERINE

TopCare

everyday

Antiseptic

Mouthwash

ANTIGINVITIS/ANTIPLAQUE

BLUE 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

8.5 FL OZ (250 mL)

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ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-664
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
SORBITOL
POLOXAMER 407
BENZOIC ACID
SACCHARIN SODIUM
SODIUM BENZOATE
FD&C GREEN NO. 3
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-664-69 250 mL in 1 BOTTLE, PLASTIC None
2 NDC:36800-664-77 500 mL in 1 BOTTLE, PLASTIC None
3 NDC:36800-664-86 1000 mL in 1 BOTTLE, PLASTIC None
4 NDC:36800-664-12 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 part356 10/26/1992
Labeler — Topco Associates LLC (006935977)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (36800-664)

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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