ANTISEPTIC MOUTH RINSE- eucalyptol mouthwash

Antiseptic Mouth Rinse by

Drug Labeling and Warnings

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

Drug Details [pdf]

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.  It antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

Inactive ingredients

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

ADA Statement

The ADA Council on Scientific  Affairs Acceptance of  Walgreens Spring Mint 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.

Disclaimer

This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine Fresh Burst

DSP-TN-1500  DSP-MO-34  SDS-TN-15012

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Well at Walgreens

ANTISEPTIC

Mouth Rinse

Antigingivitis / Antiplaque

• Freshens breath
• Improves oral hygiene
• Alcohol 21.6%

ADA

Accepted

American

Dental 

Association

SPRING MINT

Compare to FreshBurst Listerine

Antiseptic Mouthwash active ingredients

16.9 FL OZ (500 mL)

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0072
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.092 kg  in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.042 kg  in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.060 kg  in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.064 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Spring Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0072-77	0.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2007
2	NDC: 0363-0072-86	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2007
3	NDC: 0363-0072-12	1.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2007
4	NDC: 0363-0072-13	1.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2007
5	NDC: 0363-0072-88	2 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2007
6	NDC: 0363-0072-69	.25 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/30/2007

Labeler - Walgreens Co. (008965063)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(0363-0072)