SOFT MINT LISTERINE ANTISEPTIC- eucalyptol, menthol, methyl salicylate and thymol mouthwash

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK), Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A), Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ), Thymol (UNII: 3J50XA376E) (Thymol - UNII:3J50XA376E)

Available from:

Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

INN (International Name):

Eucalyptol

Composition:

Eucalyptol 0.92 mg in 1 mL

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

helps prevent and reduce: - plaque - gingivitis

Authorization status:

OTC monograph not final

Summary of Product characteristics

SOFT MINT LISTERINE ANTISEPTIC- EUCALYPTOL, MENTHOL, METHYL SALICYLATE
AND
THYMOL MOUTHWASH
JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PPC, 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._
----------
SOFT MINT
LISTERINE ANTISEPTIC
[250 ML, 500 ML, 1 L, 1.5 L]
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSES_
Eucalyptol 0.092%
Antiplaque/antigingivitis
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
US ES
helps prevent and reduce:
plaque
gingivitis
WARNINGS
DO NOT USE in children under 12 years of age
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
rinse full strength for 30 seconds with 20 ml (2/3 fluid ounce or 4
teaspoonfuls) morning and night
do not swallow
OTHER INFORMATION
store at room temperature
cold weather may cloud this product. Its antiseptic properties are not
affected.
INACTIVE INGREDIENTS
water, alcohol (21.6%), sorbitol solution, poloxamer 407, flavor,
benzoic acid, sucralose, sodium
benzoate, propylene glycol alginate, FD&C yellow no. 6, FD&C blue no.
1
QUES TIONS ?
call toll free 888-222-0182 or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL - 1.5 LITER BOTTLE LABEL
LISTERINE
SOFT MINT
ANTISEPTIC
Kills Germs that Cause
Bad Breath, Plaque & the
Gum Disease Gingivitis
ADA
ACCEPTED
American
Dental Association
1.5L (1 Qt 1 Pt 2.7 Fl OZ)
®
®
SOFT MINT LISTERINE ANTISEPTIC
eucalyptol, menthol, methyl salicylate and thymol mouthwash
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:420 0 2-40 4
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
EUCA LYPTO L (UNII: RV6 J6 6 0 4TK) (Eucalypto l - UNII:RV6 J6 6 0
4TK)
Euc a lypto l
0 .9 2 mg in 1 mL
MENTHO L (UNII: L7T10 EIP3A) (Mentho l - UNII:L7T10 EIP3A)
Me ntho l
0 .42 mg in 1 mL