ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.030%

Thymol 0.064%

purpose

antigingivituis, 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 inteneded to replace brushing or flossing

adults and children 12 years of age and older - vigorously swish 20 ml between teeth for 30 seconds then spit out

children under 12 years of age - consult a dentist or doctor

Other information

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

disclaimer

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

Adverse reactions

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2016 CVS/pharmacy

CVS.com  V-16224

072.002/072AL

principal display panel

CVS

Healh

Compare to the active ingredients in Listerine FreshBurst Antiseptic

Antiseptic

Mouthwash

ANTIGINGIVITIS/ANTIPLAQUE

Kills germs that cause plaque, gingivitis & bad breath

Green Mint

ADA

Accepted

American

Dental

Association

Sealed with printed neckband for your protection. Do not use if broken or missing.

1.5 L (50.7 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-072
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)
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: 59779-072-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/09/1995
2	NDC: 59779-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/09/1995
3	NDC: 59779-072-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/09/1995
4	NDC: 59779-072-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/09/1995
5	NDC: 59779-072-09	887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/09/1995

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/09/1995

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Vi-Jon (790752542)