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Antiseptic Mouthrinse by Wal-Mart Stores, Inc.

Dosage form: mouthwash
Ingredients: EUCALYPTOL .092kg in 100L, MENTHOL .042kg in 100L, METHYL SALICYLATE .060kg in 100L, THYMOL .064kg in 100L
Labeler: Wal-Mart Stores, Inc.
NDC Code: 49035-072

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.

Drug Facts

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 giingivitis and plaque above the gum Line, when used as directed."

Satisfaction guaranteed

- Or we'll replace it or give you your money back. Gor 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

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

wityh 90% OR MORE US PARTS

Factory Certified

1.5 LITERS (50.7 FL OZ)

ANTISEPTIC MOUTHRINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-072
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL.042 kg  in 100 L
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE.060 kg  in 100 L
THYMOL (THYMOL) THYMOL.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM CITRATE 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:49035-072-69.25 L in 1 BOTTLE, PLASTIC
2NDC:49035-072-77.5 L in 1 BOTTLE, PLASTIC
3NDC:49035-072-861 L in 1 BOTTLE, PLASTIC
4NDC:49035-072-121.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/11/1989
Labeler - Wal-Mart Stores, Inc. (051957769)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(49035-072)

Revised: 09/2016
 
Wal-Mart Stores, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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