ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic Mouth Rinse by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivits, 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 your 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 Centeer 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 for flossing

Other information

cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59° - 77° F)

inactive ingredient

water, alcohol 21.6%, sorbitol solution, flavoring, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no.10, FD&C green no. 3

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADA cOUNCIL STATEMENT

The ADA Council on Scientific Affairs Acceptance of Sunmark Spring Mint 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 Jonson & Johnson Healthcare Products, distributor of Listerine

DSP-TN-15000, DPS-MO-34, SDS-TN-15012

ADVERSE REACTIONS

Distributed by McKesson

One Post Street

San Francisco, CA 94104

Money Back Guarantee

Please visit us at

www.sunmarkbrand.com

072.002/072AL

principal display panel

sunmark

COMPARE TO LISTERINE ACTIVE INGREDIENTS

NDC: 49348-476-62

mouth

rinse

Antiseptic

ADA

Accepted

American

Dental 

Association

Kills germs that cause bad breath, plaque & the gum disease gingivitis

SPRING MINT

33.8 FL OZ (1 L)

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-476
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)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-476-62	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/1995

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/25/1995

Labeler - McKesson (177667227)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(49348-476)