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

Original Antiseptic by

Drug Labeling and Warnings

Original Antiseptic by is a Otc medication manufactured, distributed, or labeled by Topco Associates, LLC, Vi-Jon, LLC. 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

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)

INGREDIENTS AND APPEARANCE

ORIGINAL ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-318
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)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-318-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1990
2	NDC: 36800-318-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1990
3	NDC: 36800-318-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/15/1990

Labeler - Topco Associates, LLC (006935977)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(36800-318)