EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL mouthwash

Eucalyptol, Menthol, Methyl Salicylate, Thymol by

Drug Labeling and Warnings

Eucalyptol, Menthol, Methyl Salicylate, Thymol by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 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 twice a day for 30 seconds then spit out.

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

Disclaimer

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

Adverse Reactions

©2023 McKesson Corporation

Distributed by: Mckesson Corp.,

via Strategic Sourcing Services LLC

Memphis, TN 38141

Money Back Guarantee

www.foster&thrive.com

You may report serious side effects to 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

REV 07/23

DSP-TN-21091

DSP-MO-20087

Principal display panel

NDC: 70677-1232-1

COMPARE TO COOL MINT ®LISTERINE ®ANTISEPTIC MOUTHWASH*

Foster & Thrive™

ANTISEPTIC

Mouthwash

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

ANTIGINGIVITIS/ANTIPLAQUE

ADA Accepted

American Dential Association

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

BLUE MINT FLAVOR

Kills germs that cause

• Plaque
• Gingivitis
• Bad Breath

1 L (1.05 QT) 33.8 FL OZ

INGREDIENTS AND APPEARANCE

EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1232
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 BENZOATE (UNII: OJ245FE5EU)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1232-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/24/2023

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(70677-1232)