ANTISEPTIC RINSE- antiseptic mouthwash

Antiseptic Rinse by

Drug Labeling and Warnings

Antiseptic Rinse by is a Otc medication manufactured, distributed, or labeled by Meijer, Vi Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredient

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

Stop use and ask a dentist if 

• gingivitis, bleeding, or redness persists for more than 2 weeks
• you have painful or swollen guns, pus from the gun line, loose teeth or increased spacing between the teeth.  These may be signs of periodontitis, a serious form of gum disease.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children under 6 years of age.

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 twice a day for 30 seconds then spit out.  Do not swallow the rinse.
• children 6 years to under 12 years of age: supervise use
• children under 6 years of age: do not use

Other information

• this rinse is not intended to replace brushing or flossing
• 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 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

ADVERSE REACTIONS

Distributed by Meijer

124.000/124AE

principal display panel

Antiseptic

Mouth Rinse

Kills germs that cause bad breath, palque + the gum disease gingivitis

Vanilla Mint

50.7 FL OZ (1.5 L)

INGREDIENTS AND APPEARANCE

ANTISEPTIC RINSE 
antiseptic mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-124
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL ALGINATE (UNII: 26CD3J2R0C)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-124-12	1.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2006
2	NDC: 41250-124-86	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2006
3	NDC: 41250-124-77	.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/08/2006

Labeler - Meijer (006959555)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(41250-124)