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Antispetic

Safeway, Inc
Vi-Jon

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Antispetic 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

Side Effects

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)

Antispetic

Antispetic

Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-664
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
EUCALYPTOL EUCALYPTOL 0.92 mg
MENTHOL 0.42 mg
methyl salicylate METHYL SALICYLATE 0.60 mg
THYMOL THYMOL 0.64 mg

Inactive Ingredients

Ingredient Name Strength
water
ALCOHOL
sorbitol
POLOXAMER 407
BENZOIC ACID
saccharin sodium
SODIUM BENZOATE
FD&C GREEN NO. 3

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21130-664-86 1000 in 1 BOTTLE, PLASTIC
2 NDC:21130-664-12 1500 in 1 BOTTLE, PLASTIC
3 NDC:21130-664-77 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 1998-03-15


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