ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Vi-Jon

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.

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Drug Facts

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active Ingredients

Eucalyptol 0.0692%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

help 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

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

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

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

ADA Council Statement

The ADA Council on scientific affairs Acceptanc of Swan Blue Mint Antiseptic mouth rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plque 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: Vi-Jon, Inc

One Swan Drive, Smyrna, TN 37167

Principal Display Panel

Meets current TSA's guidelines for carry-on luggage

Swan

ANTISEPTIC

MOUTH RINSE

ice mint

Kills Germs that

Cause Bad Breath

Plaque & the Gum

Disease Gingivitis

Compare to active ingredients

of Listerine

Sealed with printed neckband for your protection

3.2 FL OZ (94 mL)

image description

Representative for Principal Display Panel for 

mountain

falls

Compare

to Listerine

improves

oral 

hygiene

kills germs

that cause bad

breath, plaque

and gingivitis

gum disease

for

daily

mouth

care

freshens

breath

antiseptic

mouth rinse

antiseptic

mouth rinse

antigingivitis/antiplaque

blue mint

1.5 L (50.7 FL OZ)

image description

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0664
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 BENZOATE (UNII: OJ245FE5EU)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0869-0664-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992
2 NDC:0869-0664-77 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992
3 NDC:0869-0664-69 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992
4 NDC:0869-0664-88 2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992
5 NDC:0869-0664-13 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992
6 NDC:0869-0664-12 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992
7 NDC:0869-0664-19 94 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/15/1992
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 07/15/1992
Labeler - Vi-Jon (790752542)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(0869-0664)

Revised: 5/2017
Document Id: d51db73c-5048-4b7b-a95b-07e12be2e00f
Set id: 8bdbfc38-7c14-4162-8d5f-c0bbb7765ea1
Version: 5
Effective Time: 20170502
 
Vi-Jon