ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash
Safeway Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Signature Care 318.002-318AH-AI

TEP

Sealed with printed neckband for your protection

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

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep out of reach of chrildren

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 (59°-77°F).

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

ADA Council Statement

The ADA Council on Scientific Affairs Acceptance of Signature Care Amber Antiseptic Mouthwash 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 manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine

Adverse reaction

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929 www.betterlivingbrandsLLC.com

OUR PROMISE

QUALITY & sATISFACTION

100%

GUARANTEED

OR YOUR MONEY BACK

318.003/318AH

principal display panel

Signature

Care

Quality Guaranteed

ANTISEPTIC

Mouthwash

antigingivitis/antiplaque

Amber

Fights Plaque

& Gingivitis

Compare to the

active ingredients

of Listerine

1 L

(33.8 FL OZ)

image description

ANTISEPTIC MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21130-318
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)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21130-318-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/1990

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/15/1990

Labeler - Safeway Inc. (009137209)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(21130-318)

Revised: 7/2020

Document Id: 8c0eb60a-ae6f-49cf-926e-a3306d768af6

Set id: 07d08841-262a-43df-a14f-d0c9aa93d101

Version: 6

Effective Time: 20200728

Safeway Inc.