Antiseptic mouthwash

Otc - active ingredient section

Active Ingridents Purpose
Eucalyptol 0.092% Antigingivitis, Antiplaque

Menthol 0.042% Antigingivitis, Antiplaque

Methyl salicylate 0.060% Antigingivitis, Antiplaque

Thymol 0.064% Antigingivitis, Antiplaque

Indications & usage section

Usehelps control plaque that leads to gingivitis

Warnings section

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks

you have painful or swollen guns, pus fro the gum line, loose teeth or increased spacing between the teeth. these may be signs 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 right away.

Dosage & administration section

Directions

adults and children 12 years of age and older: vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsful) between your teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.

children 6 years to under 12 years of age: supervise use

children under 6 years of age: do not use

Storage and handling section

Other information

this rinse is not intended to replace brushing or flossing

cold weather may cloud this product. Its antiseptic properties are not affected.

Store at room temperatures (59-77F)

Inactive ingredient section

Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavor, poloxamer 407, benzoic acid, sucralose and/or sodium saccharin, sodium benzoate, propylene glycol alginate, FD+C yellow no.6, FD+C blue no.1

User safety warnings section

Sealed With Printed Neckband For Your Protection

Ingredients and appearance - Product information

Antiseptic mouthwash- Antiseptic

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 67732-124
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Eucalyptol ( UNII: RV6J6604TK)( Eucalyptol - UNII: RV6J6604TK ) .092 kgin 100 L
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) .042 kgin 100 L
Menthyl salicylate ( UNII: 43XOA705ZD)( Menthyl salicylate - UNII: 43XOA705ZD ) .060 kgin 100 L
Thymol ( UNII: 3J50XA376E)( Thymol - UNII: 3J50XA376E ) .064 kgin 100 L

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Duane Reade( 011988995)

Establishment

Name ID/FEI Business Operations
Duane Reade 011988995 manufacture()

Package label.principal display panel

vanilla mint

antiseptic mouthwash

for fresher breath

kills germs that cause bad breath, plaque and the gum disease gingivitis

1 liter 33.8 fl oz