Blue Mint Mouthrinse664.003 664AT rev 2  664AU

Antispetic by

Drug Labeling and Warnings

Antispetic by is a Otc medication manufactured, distributed, or labeled by American Sales Company, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
American Sales Company

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Blue Mint Mouthrinse
664.003 664AT rev 2  664AU

Active ingredients

Eucalyptol 0.092%

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 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 unmder 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 atiseptic properties are not affected.  Store at room temperature (59° - 77°F)

Inactive ingredients

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

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

Distributed by Foodhold USA, LLC

Landover, MD 20785

1-877-845-9949

(c)2018 S&S Brands, LLC

Quality guaranteed or your money back

DSP-TN-15000  DSP-MO-34   SDS-TN-15012

664.002/664AS

Principal display panel

Care One

Compare to Cool Mint Listerine Antiseptic Mouthwash*

Antiseptic Mouth rinse

Antigingivitis/Antiplaque

Kills Germs that Cause bad breath, plaque and the gum disease gingivitis

Blue Mint flavor

Sealed with printed neckband for your protection

8.5 FL OZ (250 mL)

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-664
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: 41520-664-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1992	10/23/2023
2	NDC: 41520-664-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1992	10/23/2023
3	NDC: 41520-664-19	94 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1992	10/23/2023
4	NDC: 41520-664-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1992	10/23/2023
5	NDC: 41520-664-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/1992	10/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	09/15/1992	10/23/2023

Labeler - American Sales Company (809183973)

Registrant - Vi-Jon, LLC (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(41520-664)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		088520668	manufacture(41520-664)

Revised: 10/2023

Document Id: f49c5825-bcd5-4ca4-a9ac-2a828faef0b5

34390-5

Set id: 226d6e52-2b1b-41a8-9801-4f603abe5d4c

Version: 3

Effective Time: 20231023