MOUTHWASH- menthol, methyl salicylate, thymol liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E), EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Orazen Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antigingivitis, Antiplaque Uses Helps reduce plaque that leads to - gingivitis - bleeding gums
Authorization status:
OTC monograph not final
Authorization number:
71927-006-01

MOUTHWASH- menthol, methyl salicylate, thymol liquid

Orazen Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

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

Purpose

Antigingivitis, Antiplaque

Uses

Helps reduce plaque that leads to

gingivitis

bleeding gums

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 under 6 years of age . If more than used for rinsing is accidentally

swallowed, get medical help or contact a Poison Control Center immediately.

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

supervise use

children uner 6 years of

do not use

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 ingredients

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

sorbitol, water

MOUTHWASH

menthol, methyl salicylate, thymol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:719 27-0 0 6

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

0 .6 mg in 1 mL

THYMO L (UNII: 3J50 XA376 E) (THYMOL - UNII:3J50 XA376 E)

THYMOL

0 .6 4 mg in 1 mL

EUCALYPTO L (UNII: RV6 J6 6 0 4TK) (EUCALYPTOL - UNII:RV6 J6 6 0 4TK)

EUCALYPTOL

0 .9 2 mg in 1 mL

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

0 .42 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO RBITO L (UNII: 50 6 T6 0 A25R)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:719 27-0 0 6 -0 1 251 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/22/20 19

Marketing Information

Orazen Inc

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 4/22/20 19

Labeler -

Orazen Inc (080916640)

Revised: 4/2019

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