ANTISEPTIC - eucalyptol, menthol, metyl salicylate, thymol rinse
McKesson

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.

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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

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Please visit us at

www.sunmarkbrand.com

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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)

image description

ANTISEPTIC
eucalyptol, menthol, metyl salicylate, thymol rinse

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49348-480-62	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/19/2009	11/17/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	05/19/2009	11/17/2021

Labeler - McKesson (177667227)

Registrant - Vi-Jon (790752542)

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

Revised: 11/2021

Document Id: 92f8eb51-2bba-4987-b92f-beac256f485e

Set id: 00691789-6508-4629-b00b-763d32dae600

Version: 3

Effective Time: 20211117

McKesson