OTC Medication Information: Antispetic

ANTISPETIC- eucalyptol, menthol, methyl salicylate and thymol mouthwash
CVS Pharmacy, Inc

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

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 unmder 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 (59°-77°F)

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, green 3

Disclaimer

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

Sealed with printed neckband for your protection. Do not use if broken or missing.

This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Cool Mint Listerine Antiseptic Mouthwash.

Meets current TSA guidelines for carry-on luggage.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsacket, RI 02895

(c) 2023 CVS Pharmacy, Inc.

CVS.com V-13687

1-800-SHOP-CVS

DSP-TN-21091

DSP-MO-20087

principal display panel

CVS

Health

Compare to the active ingredints in Listerine Cool Mint Antiseptic*

Antiseptic

Mouthwash

ANTIGINGIVITIS/ANTIPLAQUE

Kills gemrs that cause plaque, gingivitis & bad breath

Blue Mint

ADA

Accepted

American

Dental

Association

  • Helps prevent and reduce plaque
  • Helps prevent and reduce gingivitis

3.2 FL OZ (94 mL)

image description
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ANTISPETIC
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-664
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:59779-664-69 250 mL in 1 BOTTLE, PLASTIC None
2 NDC:59779-664-19 94 mL in 1 BOTTLE, PLASTIC None
3 NDC:59779-664-13 1250 mL in 1 BOTTLE, PLASTIC None
4 NDC:59779-664-86 1000 mL in 1 BOTTLE, PLASTIC None
5 NDC:59779-664-12 1500 mL in 1 BOTTLE, PLASTIC None
6 NDC:59779-664-77 500 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 09/15/1992
Labeler — CVS Pharmacy, Inc (062312574)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (59779-664)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (59779-664)

Revised: 04/2023 CVS Pharmacy, Inc

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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