ANTISEPTIC MOUTHRINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic Mouthrinse by

Drug Labeling and Warnings

Antiseptic Mouthrinse by is a Otc medication manufactured, distributed, or labeled by CDMA, Consumer Product Partners, 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

help control plaque that leads to gingivitis

Warnings

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 - 77⁰ F)

Inactive ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, D&C yellow no. 10, FD&C green no.3

Disclaimer

This product is not manufatured or distriubted by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.

Adverse Reactions

Distributed by C.D.M.A., Inc

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-93-2362

Principal display panel

QC

QUALITY

CHOICE

Compare to FreshBurst

LISTERINE

Antiseptic Mouth Rinse

Antigingivitis/Antilaqu

Kills Germs That Cause:

Bad Breath

Plaque

Gingivitis

Gum Disease

Spring Mint

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTHRINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-181
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	0.6 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)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-181-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/02/2024

Labeler - CDMA (011920774)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(83324-181)