ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.030%

Thymol 0.064%

purpose

antigingivituis, 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 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 or flossing

Other information

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

inactive ingredients

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

Questions?

Or to report an adverse even call 800-824-1706

Monday - Friday 9am -4pm MST

ADA Council Statement

"The ADA Council on Scientific Affairs" Acceptance of WinCo Foods Spring Mint Antisetpic Mouth Rinse is based on its finding that the product is

effective in helping to prevent and reduct 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 Freshburst LISTERINE

Antiseptic Mouthwash.

Adverse reactions

DISTRIBUTED BY:WINCO FOODS, LLC BOISE, ID 83704

Comments & Questions?

800-824-1706  www.wincofoods.com

072.001/072AL

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTIO

Compare to the active ingredients in Freshburst LISTERINE Antiseptic Mouthwash

WinCo

FOODS

ANTISEPTIC 

MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE MOUTH RINSE

Kills Germs That Cause Bad Breath, Plaque and Gingivitis Gum Disease

For Better Oral Hygiene and Fresher Breath

ADA

Accepted 

American

Dental

Association

Spring Mint

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-102
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: 67091-102-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/03/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/03/2014

Labeler - WinCo Foods, LLC (056098817)

Registrant - Vi-Jon (790752542)