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NDC 41190-0124-86 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 Wakefern Food Corp. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	41190-0124
Product ID	41190-124_5fca05ee-07e2-40db-819a-cf3aa12952a9
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	Wakefern Food Corp
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 41190-0124-86 (41190012486)

Pricing Information	N/A
NDC Package Code	41190-124-86
Billing NDC	41190012486
Package	1000 mL in 1 BOTTLE, PLASTIC (41190-124-86)
Marketing Start Date	2009-08-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d2db510a-9e31-47e8-adb7-5fd7776f6718 Details

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 swollem 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 the rinse

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, sucralose and/or sodium saccharin, sodium benzoate, propylene glycol alginate, FD&C yellow no. 6, FD&C blue no. 1

SPL UNCLASSIFIED SECTION

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

Distributed By

Wakefern Food Corp.

5000 Riverside Drive

Keasbey, NJ 08832

Call:1-800-shoprite

principal display panel

Compare to the Active Ingredients of LISTERINE*

SHOPRITE

Antiseptic Mouth Rinse

Helps to kill germs that cause plaque, gingivitis and bad breath

VANILLA MINT

Sealed With Printed Neckband For Your Protection

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISPETIC

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-124
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)
PROPYLENE GLYCOL ALGINATE (UNII: 26CD3J2R0C)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-124-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/04/2009

Labeler - Wakefern Food Corp (069722418)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41190-124)

Revised: 6/2022

Document Id: 5fca05ee-07e2-40db-819a-cf3aa12952a9

Set id: d2db510a-9e31-47e8-adb7-5fd7776f6718

Version: 12

Effective Time: 20220630