ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%, Antigingivitis, Antiplaque

Available from:

Hy-Vee, Inc.

INN (International Name):

EUCALYPTOL

Composition:

EUCALYPTOL .092 kg in 100 L

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

helps control plaque that leads to gingivitis

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTISEPTIC MOUTH RINSE- EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
MOUTHWASH
HY-VEE, 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._
----------
DRUG FACTS 072 072.003/072AL REV 2
ACTIVE INGREDIENTS
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
PURPOS E
Antigingivitis, Antiplaque
US E
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 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 (59 - 77 F)
INACTIVE INGREDIENTS
water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407,
benzoic acid, sodium saccharin, sodium
citrate, D&C yellow no. 10, FD&C green no. 3
ADA SEAL INFORMATION
The ADA Council on Scientific Affairs Acceptance of Mint Antiseptic
Mouth Rinse is based on it
finding that the product is effective in helping to
revent and reduct gingivitis and plaque above the gumline, when used
as directed.
This product is not manufactured or distributed by Johnson + Johnson
Healthcare Products, distributor
of Listerine
DSP-TN-15000, DSP-MO-34, SDS-TN-15012
ADVERSE REACTION
DISTRIBUTED