MOUTHWASH- menthol, methyl salicylate, thymol liquid

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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)

Disponible depuis:

Orazen Inc

Mode d'administration:

ORAL

Type d'ordonnance:

OTC DRUG

indications thérapeutiques:

Purpose Antigingivitis, Antiplaque Uses Helps reduce plaque that leads to - gingivitis - bleeding gums

Statut de autorisation:

OTC monograph not final

Résumé des caractéristiques du produit

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
age
supervise use
children uner 6 years of
age
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