ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic Mouth Rinse by

Drug Labeling and Warnings

Antiseptic Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep out of reach of chrildren

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 twice a day 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 (59°-77°F).

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Disclaimer

This product is manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of  Original Listerine Antiseptic Mouthwash

Adverse reactions

Distributed by:  CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

318.003/318AH

2019 CVS/pharmacy

CVS.com 1-800-SHOPCVS

Made in the U.S.A. of U.S. and oreign components

V-16224

CVS Quality

Money Back Guarantee

DSP-TN-15000

DSP--MO-34

SDS-TN-15012

318.003/318AH

principal display panel

Compare to the active ingredients in Listerine Original Antiseptic

CVS

Health

Antiseptic

Mouthwash

ANTIGINGIVITIS/ANTPLAQUE

Kills gemrs that cause plaque, gingivitis & bad breath

Original

ADA

Accepted

American

Dental

Association

• Helps reduce plaque
• Helps reduce gingivitis

Sealed with printed neckband for your protection.

Do not use if broken or missing

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-898
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-898-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2009
2	NDC: 59779-898-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/12/2009

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(59779-898)