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Antiseptic Mouth rinse by American Sales Company

Medically reviewed on September 13, 2017

Dosage form: mouthwash
Ingredients: EUCALYPTOL .092kg in 100L, MENTHOL .042kg in 100L, METHYL SALICYLATE .060kg in 100L, THYMOL .064kg in 100L
Labeler: American Sales Company
NDC Code: 41520-210

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

Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%

Purpose
Antigingivitis, Antiplaque

Use helps control plaque that leads to gingivitis

Warnings

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 (59⁰ - 77⁰ F)

Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine

DISTRIBUTED BY
AMERICAN SALES COMPANY
4201 WALDEN AVENUE
LANCASTER, NY14086

QUALITY GUARANTEED OR YOUR MONEY BACK

DSP-TN-15000
DSP-MO-34
SDS-TN-15012

Compare to Citrus Advanced Listerine with Tartar Protection
Sealed with Printed Neckband for Your protection  
Care One
Antiseptic
MOUTH
RINSE
Tartar protection + Control
Citrus flavor
•Helps fight tartar buildup
•Fights plaque and gingivitis
• Kills germs for extended plaque protection
• Enhanced breath protection
1 Liter
(33.8 FL OZ)

ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL.042 kg  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE.060 kg  in 100 L
THYMOL (THYMOL) THYMOL.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
POLOXAMER 407 
BENZOIC ACID 
ZINC CHLORIDE 
SUCRALOSE 
SODIUM BENZOATE 
Packaging
#Item CodePackage Description
1NDC:41520-210-131.25 L in 1 BOTTLE, PLASTIC
2NDC:41520-210-861 L in 1 BOTTLE, PLASTIC
3NDC:41520-210-121.5 L in 1 BOTTLE, PLASTIC
4NDC:41520-210-69.25 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/02/2010
Labeler - American Sales Company (809183973)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture

 
American Sales Company

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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