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Antiseptic by McKesson

Medically reviewed on June 8, 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

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 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

ADA Statement

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.

Adverse reaction

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

664.002/664AS

principal display panel

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 (SALICYLIC ACID) 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 
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(49348-482)

 
McKesson

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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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