ANTISEPTIC- eucalyptol, menthol, metyl salicylate, thymol rinse

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by McKesson, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ANTISEPTIC  
eucalyptol, menthol, metyl salicylate, thymol rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-480
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-480-62	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/19/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/19/2009

Labeler - McKesson (177667227)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(49348-480)