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Antiseptic by McKesson

Medically reviewed on Jun 7, 2018

Dosage form: rinse
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.60mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: McKesson
NDC Code: 49348-480

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

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active

Eucalyptol 0.092%, Menthol 0.042%  Methyl salicylate 0.060%, Thymol 0.064%

Purtpose

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 dentst 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 (57-77 F)

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

ADA Council Statement

"The ADA Council On Scientific Affairs Acceptance of Sunmark 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."

Disclaimer

This product is not manufactured or distributed by Johnson  Johnson Healthcare Products,

distributor of Listerine.

Adverse Reactions

Another Quality Product

Distributed by McKesson

One Post Street

San Francisco , CA 94104

Money Back Guarantee

Please visit us at

www.sunmarkbrand.com

Principal Display Panel

suncmark

COMPARE TO

LISTERINE

ACTIVE INGREDIENTS

NDC 49348-480-62

mouth

rinse

Antiseptic

ADA

Accepted

American

Dental

Associatgion

Kills germs that cause

bad breath, plaque & the

gum disease gingvitis

ORIGINAL FLAVOR

33.8 FL OZ (1L)

ANTISEPTIC  
eucalyptol, menthol, metyl salicylate, thymol rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-480
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
BENZOIC ACID 
POLOXAMER 407 
SODIUM BENZOATE 
CARAMEL 
Packaging
#Item CodePackage Description
1NDC:49348-480-621000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/19/2009
Labeler - McKesson (177667227)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(49348-480)

 
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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