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Original Antiseptic by Topco Associates, LLC

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.60mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: Topco Associates, LLC
NDC Code: 36800-318

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

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 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
  • do not swallow
  • not intended to replace brushing or flossing

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

Other information

Store at room temperature (59°-77°F).

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

ADA Council Statement

The ADA Council on Scientific Affairs’ Acceptance of TopCare Amber 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 Johnson & Johnson Healthcare Products, distributor of Listerine

Adverse Reactions

DISTRIBUTED BY: TOPCO ASSOCIATES LLC

7711 GROSS POINT ROADK, SKOKIE, IL 60077

TOPCO  CSW1006

QUESTIONS? 1-888-423-0139    topcare@copco.com

318.003/318AH

Principal Display Panel

Sealed With Printed Neckband For Your Protection

TOP CARE

AMBER

Antiseptic

Mouth

Rinse

ADA

Accepted

American

Dental

Association

Kills Germs that Cause

Bad Breath,

Plaque, & the

Gum Disease

Gingivitis

QUALITY GUARANTEED

COMPARE TO LISTERINE

active ingredients

1.5 LITERS (50.7 FL OZ)

ORIGINAL ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-318
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
BENZOIC ACID 
POLOXAMER 407 
SODIUM BENZOATE 
CARAMEL 
Packaging
#Item CodePackage Description
1NDC:36800-318-861000 mL in 1 BOTTLE, PLASTIC
2NDC:36800-318-69250 mL in 1 BOTTLE, PLASTIC
3NDC:36800-318-121500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/15/1990
Labeler - Topco Associates, LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(36800-318)

 
Topco Associates, LLC

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Medically reviewed on Apr 23, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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