Your browser does not support JavaScript! ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [SAFEWAY, INC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

ANTISPETIC (eucalyptol, menthol, methyl salicylate, thymol) mouthwash
[Safeway, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

TEP

Sealed with printed neckband for your protection

Active ingredients

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

Inactive ingredients

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

ADA Council Statement

The ADA Council on Scientific Affairs Acceptance of Safeway Blue Mint Antiseptic Mouthwash is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plque above the gumline, when used as directed

Adverse Reactions

DISTRIBUTED BY SAFEWAY INC.

P.O. BOX 99

PLEASANTON, CA 94566-0009

1-888-SAFEWAY/www.safeway.com

PRODUCT OF U.S.A.

Principal display panel

SAFEWAY

CARE

Quality Guaranteed

ANTISEPTIC

Mouthwasy

antigingivitis/antiplaque

Blue Mint

Fights plaque & gingivitis

Kills germs that cause bad breath

ADA

Accepted

American

Dental

Association

500 mL

(16.9 FL OZ)

image description

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:21130-664
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-664-861000 mL in 1 BOTTLE, PLASTIC
2NDC:21130-664-121500 mL in 1 BOTTLE, PLASTIC
3NDC:21130-664-77500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/15/1998
Labeler - Safeway, Inc (009137209)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(21130-664)

Revised: 4/2014
 
Safeway, Inc

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services