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 Family Dollar Services, 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%

Tymol 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 dentst 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 brushig 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 not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the distributor of Listerine.

DSP-TN-15000   DSP-MO-34   SDS-TN-15012

Adverse Reactions

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD,

MATTHEWS, NC 28105 USA

Not 100% satisfied? Return package and unused product within 30
days to any Family Dollar store for a refund (with receit) or exchange

Made in U.S.A. with U.S. and foreign components 

318.003/318AH

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

NDC: 55319-318-86

FAMILY

WELLNESS

COMPARE TO THE ACTIVE

INGREDENTS OF LISTERINE

100% SATISFACTION

OR YOUR MONEY BACK

GUARANTEED

Antiseptic

Mouth Rinse

Kills Germs That Cause

Bad Breath, Plaque and

The Gum Disease Gingivitis

1 L (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: 55319-318
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: 55319-318-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/22/1991
2	NDC: 55319-318-13	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/22/1991
3	NDC: 55319-318-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/22/1991

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/22/1991

Labeler - Family Dollar Services, Inc (024472631)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55319-318)