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NDC 63868-0214-86 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 Chain Drug Manufacturing Assn. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	63868-0214
Product ID	63868-214_43d7d0aa-f0e9-46c0-8b0a-a90c8c6841b9
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	Chain Drug Manufacturing Assn
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 63868-0214-86 (63868021486)

Pricing Information	N/A
NDC Package Code	63868-214-86
Billing NDC	63868021486
Package	1000 mL in 1 BOTTLE, PLASTIC (63868-214-86)
Marketing Start Date	2010-12-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3d5fa47f-054b-42a0-8318-7dc406194165 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

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 (59⁰ - 77⁰ F)

Inactive ingredients

water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, D&C yellow no. 10, FD&C green no.3

Disclaimer

This product is not manufatured or distriubted by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.

Adverse Reactions

Distributed by C.D.M.A., Inc

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-93-2362

principal display panel

QUALITY

CHOICE

Compare to FreshBurst

LISTERINE

Antiseptic Mouth Rinse

Antigingivitis/Antilaqu

Kills Germs That Cause:

Bad Breath

Plaque

Gingivitis

Gum Disease

Spring Mint

1 L (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:63868-214
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 CITRATE (UNII: 1Q73Q2JULR)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-214-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/28/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	12/28/2010

Labeler - Chain Drug Manufacturing Assn (011920774)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(63868-214)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(63868-214)

Revised: 4/2022

Document Id: 43d7d0aa-f0e9-46c0-8b0a-a90c8c6841b9

Set id: 3d5fa47f-054b-42a0-8318-7dc406194165

Version: 13

Effective Time: 20220406