ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Antiseptic by

Drug Labeling and Warnings

Antiseptic by is a Otc medication manufactured, distributed, or labeled by 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

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

• this rinse is not intended to replace brushing or flossing

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, Inc

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)

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)

INGREDIENTS AND APPEARANCE

ANTISEPTIC  
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0072
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: 0869-0072-21	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/1988
2	NDC: 0869-0072-88	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/1988
3	NDC: 0869-0072-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/1988
4	NDC: 0869-0072-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/1988
5	NDC: 0869-0072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/1988
6	NDC: 0869-0072-19	94 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/1988
7	NDC: 0869-0072-50	710 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/1988
8	NDC: 0869-0072-13	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/1988
9	NDC: 0869-0072-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/1988

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/20/1988

Labeler - Vi Jon, Inc (790752542)

Registrant - Vi Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon, Inc		790752542	manufacture(0869-0072)