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Antiseptic by McKesson

Medically reviewed on May 21, 2018

Dosage form: rinse
Ingredients: EUCALYPTOL .092kg in 100L, MENTHOL .042kg in 100L, METHYL SALICYLATE .060kg in 100L, THYMOL .064kg in 100L
Labeler: McKesson
NDC Code: 49348-482

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 you 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 of flossing

Other information cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (57⁰-77⁰F)

Inactive ingredients water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin,
sodium benzoate, FD+C green no. 3

The ADA council on Scientific affairs Acceptance of Sunmak's Antiseptic Mouth Rinse is based on
its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline when used as directed.

This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Listerine.

Another Quality Product
Distributed by McKesson
One Post Street
San Francisco, CA 94104
Money Back Quarantee
Please visit us at
www.sunmarkbrand.com
DSP-TN-15000
DSP-MO-34
SDS-TN-15012

SUNMARK
Compare to
Listerine
Active Ingredients
NDC 49348-482-62
MOUTH
Rinse
Antiseptic
ADA
Accepted
Kills germs that cause
bad breath, plaque + the
gum disease gingivitis
BLUE MINT
33.8 FL OZ ( 1 L)
ANTISEPTIC  
eucalyptol,menthol, methyl salicylate, thymol rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-482
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
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM DIHYDRATE 
SODIUM BENZOATE 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:49348-482-621 L in 1 BOTTLE, PLASTIC
2NDC:49348-482-891.25 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/15/1990
Labeler - McKesson (177667227)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture

 
McKesson

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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