ANTISEPTIC- eucayptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, Inc, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl saliclate 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 gun line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serous 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

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 teaspoonsfuls) 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 properites are not affected. Store at room temperature (59°-77°F).

inactive ingredients

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

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mouthwash

Adverse Reactions Section

Distributed by

Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269

1-866-696-0957 www.valuelabels.com

318.003/318AH

Principal display panel

GoodSense

NDC: 5084-318-69

Sealed With Printed Neckband For Your Protection

Antiseptic Mouth Rinse

Original

Kills Germs That Cause

Bad Breath, Plaque & The Gum Disease Gingivitis

ADA Accepted American Dental Association

“The ADA Council on Scientific Affairs’ Acceptance of Good Sense Original 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.”

Compare to active ingredients of Listerine

1 Liter (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
eucayptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-318
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: 50804-318-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1990
2	NDC: 50804-318-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1990
3	NDC: 50804-318-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1990
4	NDC: 50804-318-13	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	09/15/1990

Labeler - Geiss, Destin & Dunn, Inc (076059836)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(50804-318)