ANTISEPTIC - eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Vi Jon, LLC

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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Swan Mountain Falls 072.003/072AN

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

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

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

inactive ingredents

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

ADA council statement

“The ADA Council on Scientific Affairs’ Acceptance of Swan Spring Mint® 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.”

safety information

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

disclaimer

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

DSP-TN-1500  DSP-MO-34 SDS-TN-15012

Adverse Reactions

Distributed By: Vi-Jon, LLC

8515 Page Ave.,  St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

principal display panel

NDC 0869-0072-69

Sealed With Printed Neckband For Your Protection

SWAN

ANTISEPTIC

MOUTH RINSE

spring mint

Kills Germs that Cause

Bad Breath, Plaque & the

Gum Disease Gingivitis

Compare to FreshBurst Listerin

ADA

Accepted

American

Dental

Association

250 mL (8.5 FL OZ)

image description

principal display panel

Mountain

Falls

Compare to Listerine

improves oral hygiene

for daily mouth care

kills germs that cause bad breath, plaque and gingivitis gum disease

freshens breath

antiseptic

mouth rinse

antigingivitis/antiplaque

spring mint

500 mL (16.9 FL OZ)

image description

ANTISEPTIC  
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0072
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0072-2189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
2NDC:0869-0072-882000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
3NDC:0869-0072-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
4NDC:0869-0072-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
5NDC:0869-0072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
6NDC:0869-0072-1994 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
7NDC:0869-0072-50710 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
8NDC:0869-0072-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
9NDC:0869-0072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/1988
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/20/1988
Labeler - Vi Jon, LLC (790752542)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(0869-0072)

Revised: 2/2022
Document Id: 7fd71b84-58b0-45dc-a5a8-a2633ecbb9fd
Set id: 70ee47e6-49cb-4ede-869d-cbad61ddcedc
Version: 18
Effective Time: 20220202
 
Vi Jon, LLC