ANTISEPTIC - eucalyptol,menthol, methyl salicylate, thymol rinse
Strategic Sourcing Services LLC

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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Sunmark 664.003 664AU

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)

image description

ANTISEPTIC
eucalyptol,menthol, methyl salicylate, thymol rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-482
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	.092 kg in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.042 kg in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.060 kg in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	.064 kg in 100 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49348-482-62	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/1990	08/04/2023
2	NDC:49348-482-89	1.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/1990	08/04/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/1990	08/04/2023

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(49348-482)

Revised: 12/2021

Document Id: 8dc7d532-d6a4-4f06-8b2b-357f0dd4723f

Set id: be1f5ba0-be8c-4a0e-b728-4d43278b3334

Version: 9

Effective Time: 20211216

Strategic Sourcing Services LLC