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NDC 49348-0482-89 Antiseptic .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L Details

Antiseptic .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L

Antiseptic is a ORAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL.

Product Information

NDC	49348-0482
Product ID	49348-482_8dc7d532-d6a4-4f06-8b2b-357f0dd4723f
Associated GPIs	88300000000900
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	Antiseptic
Proprietary Name Suffix	n/a
Non-Proprietary Name	EUCALYPTOL,MENTHOL, METHYL SALICYLATE, THYMOL
Product Type	HUMAN OTC DRUG
Dosage Form	RINSE
Route	ORAL
Active Ingredient Strength	.092; .042; .06; .064
Active Ingredient Units	kg/100L; kg/100L; kg/100L; kg/100L
Substance Name	EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	n/a

Package

Package Images

NDC 49348-0482-89 (49348048289)

Pricing Information	N/A
NDC Package Code	49348-482-89
Billing NDC	49348048289
Package	1.25 L in 1 BOTTLE, PLASTIC (49348-482-89)
Marketing Start Date	1990-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL be1f5ba0-be8c-4a0e-b728-4d43278b3334 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 you 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 of flossing

Other information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (57⁰-77⁰F)

Inactive ingredients

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

ADA Statement

The ADA council on Scientific affairs Acceptance of Sunmak's Antiseptic Mouth Rinse 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 Pfizer Consumer Healthcare, distributor of Listerine.

Adverse reaction

Another Quality Product

Distributed by McKesson

One Post Street

San Francisco, CA 94104

Money Back Quarantee

Please visit us at

www.sunmarkbrand.com

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

664.002/664AS

principal display panel

SUNMARK

Compare to

Listerine

Active Ingredients

NDC 49348-482-62

MOUTH

Rinse

Antiseptic

ADA

Accepted

Kills germs that cause bad breath, plaque & the gum disease gingivitis

BLUE MINT

33.8 FL OZ ( 1 L)

INGREDIENTS AND APPEARANCE

ANTISEPTIC

eucalyptol,menthol, methyl salicylate, thymol rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-482
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	.092 kg in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.042 kg in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.060 kg in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	.064 kg in 100 L

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	Marketing End Date
Packaging
1	NDC:49348-482-62	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/1990	08/04/2023
2	NDC:49348-482-89	1.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/1990	08/04/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/1990	08/04/2023

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(49348-482)

Revised: 12/2021

Document Id: 8dc7d532-d6a4-4f06-8b2b-357f0dd4723f

Set id: be1f5ba0-be8c-4a0e-b728-4d43278b3334

Version: 9

Effective Time: 20211216