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NDC 36800-0664-12 Antispetic .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL Details

Antispetic .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL

Antispetic is a ORAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	36800-0664
Product ID	36800-664_92db15b5-67d5-4365-9fcf-fec00c98d7b0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Antispetic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Eucalyptol, menthol, methyl salicylate, thymol
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	ORAL
Active Ingredient Strength	.92; .42; .6; .64
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Labeler Name	Topco Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0664-12 (36800066412)

Pricing Information	N/A
NDC Package Code	36800-664-12
Billing NDC	36800066412
Package	1500 mL in 1 BOTTLE, PLASTIC (36800-664-12)
Marketing Start Date	1992-10-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a1915524-2719-40d4-86e3-35df5ce3238d Details

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

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

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 Acceptance of CVS/pharmacy Blue Mint Antiseptic Mouthwash is based on its finding that the product is effectie in helping to prevent and reduce gingivitis and plaque 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

DIST BY TOPCO ASSOCIATES LLC

7711 GROSS PROINT ROAD

SKOKIE, IL 60077

QUESTIONS? 1-888-423-0139

[email protected]

principal display panel

COMPARE TO LISTERINE

TopCare

everyday

Antiseptic

Mouthwash

ANTIGINVITIS/ANTIPLAQUE

BLUE MINT

For better oral hygiene & fresher breath
Kills germs that cause bad breath, plaque & the gum disease gingivitis

ADA

Accepted

American Dental Association

Helps reduce plaque
Helps reduce gingivitis

8.5 FL OZ (250 mL)

INGREDIENTS AND APPEARANCE

ANTISPETIC

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-664
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-664-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/1992
2	NDC:36800-664-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/1992
3	NDC:36800-664-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/1992
4	NDC:36800-664-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/26/1992

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	10/26/1992

Labeler - Topco Associates LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-664)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-664)

Revised: 5/2022

Document Id: 92db15b5-67d5-4365-9fcf-fec00c98d7b0

Set id: a1915524-2719-40d4-86e3-35df5ce3238d

Version: 11

Effective Time: 20220524