ANTISEPTIC MOUTHRINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic Mouthrinse by

Drug Labeling and Warnings

Antiseptic Mouthrinse by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEP

Sealed with printed neckband for your protection

Active ingredients

Eucalyptol 0.092%, Menthol 0.042%, Methyl sailcylate 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 incresed 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 rednss 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 under 12 years if 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.  Its antiseptic propeties 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

ADA Council Statement

"The ADA Council on Scientific Affairs'  Acceptance of Equate Spring Mint Antiseptic Mouthrinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gum Line, when used as directed."

Satisfaction guaranteed

- Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

Adverse Reactions Section

DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered mark FreshBurst Listerine

072.002/027AL

principal display panel

equate

Compare to FreshBurst

Listerine

Active

Ingredients

Antiseptic

Mouthrinse

Kills Germs that Cause:

• Plaque
• Gingivitis
• Bad breath

ADA

Accepted

American Dental Association

Spring Mint

Made in the

USA

with 90% OR MORE US PARTS

Factory Certified

1.5 LITERS (50.7 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTHRINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-072
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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: 49035-072-69	.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/1989
2	NDC: 49035-072-77	.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/1989
3	NDC: 49035-072-86	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/1989
4	NDC: 49035-072-12	1.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/1989

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/11/1989

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(49035-072)