ANTISPETIC- eucalyptol, menthol, methyl salicylate and 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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Drug Facts

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:21130-664
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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
Inactive Ingredients
Ingredient Name Strength
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21130-664-86 1000 mL in 1 BOTTLE, PLASTIC
2 NDC:21130-664-12 1500 mL in 1 BOTTLE, PLASTIC
3 NDC:21130-664-77 500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 03/15/1998
Labeler - Safeway, Inc (009137209)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(21130-664)

Revised: 4/2014
Document Id: c6446f86-864b-48fc-a9f4-357a37c1311b
Set id: c2c6a591-c2fd-47ac-bf80-41e6030fdd75
Version: 2
Effective Time: 20140416
 
Safeway, Inc