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NDC 41250-0664-19 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 Meijer Distribution Inc.. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	41250-0664
Product ID	41250-664_a8a2f277-1573-480a-a504-f414905c8712
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	Meijer Distribution Inc.
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 41250-0664-19 (41250066419)

Pricing Information	N/A
NDC Package Code	41250-664-19
Billing NDC	41250066419
Package	94 mL in 1 BOTTLE, PLASTIC (41250-664-19)
Marketing Start Date	1993-08-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2aacfe5c-36c8-4890-b6c0-a9511346761e Details

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 ingredients

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

Rear Label Text

"The ADA Council on Scientific Affairs Acceptance of Meijer Blue Mint Antiseptic Mouthwash 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."

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

Sealed With Printed Neckband For Your Protection

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.com

principal display panel

Compare to

Cool Mint Listerine

active ingredients

meijer

Blue Mint

Mouthwash

Antigingivitis/Antiplaque

Antiseptic

Kills germs that cause bad breath, plaque and gingivitis

Cleans the entire mouth

ADA

Accepted

American

Dental

Association

33.8 FL OZ (1L)

INGREDIENTS AND APPEARANCE

ANTISPETIC

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-664
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:41250-664-19	94 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/11/1993
2	NDC:41250-664-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/11/1993
3	NDC:41250-664-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/11/1993
4	NDC:41250-664-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/11/1993
5	NDC:41250-664-44	532 mL in 1 PACKAGE; Type 0: Not a Combination Product	08/11/1993
6	NDC:41250-664-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/11/1993
7	NDC:41250-664-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/11/1993
8	NDC:41250-664-13	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/11/1993

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/11/1993

Labeler - Meijer Distribution Inc. (006959555)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41250-664)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41250-664)

Revised: 5/2022

Document Id: a8a2f277-1573-480a-a504-f414905c8712

Set id: 2aacfe5c-36c8-4890-b6c0-a9511346761e

Version: 16

Effective Time: 20220517