MOUTHWASH- menthol, methyl salicylate, thymol liquid

Mouthwash by

Drug Labeling and Warnings

Mouthwash by is a Otc medication manufactured, distributed, or labeled by Orazen Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
EUCALYPTOL 0.092%, MENTHOL 0.042%, METHYL SALICYLATE 0.060%, THYMOL 0.064%

PURPOSE

Purpose
Antigingivitis, Antiplaque

INDICATIONS & USAGE

Uses
Helps reduce plaque that leads to

• gingivitis
• bleeding gums

WARNINGS

Warnings

Stop use and see your dentist immediately if

• gingivitis, bleeding or redness persists for more than 2 weeks
• you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth

These may be signs or symptoms of periodontitis, a serious form of gum disease.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age . If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• adult and children 12 years of age and older: vigorously swish 20 millliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.
• children 6 to 20 years of age: supervise use
• children uner 6 years of age: do not use

OTHER SAFETY INFORMATION

Other information

• not intended to replace brushing or flossing
• store at room temperature (59-77F)
• cold weather may cloud this product, but will not affect its antiseptic properties.

INACTIVE INGREDIENT

Inactive ingredients
alcohol (21.6%), benzoic acid, flavor, green 3, poloxamer 407, sodium benzoate, sodium saccharin, sorbitol, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOUTHWASH 
menthol, methyl salicylate, thymol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-006-01	251 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/22/2019

Labeler - Orazen Inc (080916640)