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Name:Antiseptic
Manufacturer:Dza Brands, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTISEPTIC   - eucalyptol, menthol, methyl salicylate and thymol rinse 
DZA Brands, LLC

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

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

Do not use if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See you 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 of flossing



Other information cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (57⁰-77⁰F)

Inactive ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, caramel

Distributed by: DZA Brands, LLC
2110 Executive Drive
Salisbury, NC 28147  

For product questions or concerns contact
us at 1-866-322-2439.  Please include
UPC number and Code from package.

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
Healthy
Accents
original flavor
antiseptic
mouth rinse
kills germs that cause bad breath,
plaque + the gum disease gingivitis

compare to the active
ingredients of Listerine

1 Liter (33.8 FL OZ)
image of principal display panel


ANTISEPTIC  
eucalyptol rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-318
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL .092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL .042 kg  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE .060 kg  in 100 L
THYMOL (THYMOL) THYMOL .064 kg  in 100 L
Inactive Ingredients
Ingredient Name Strength
WATER  
ALCOHOL  
BENZOIC ACID  
POLOXAMER 407  
CARAMEL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55316-318-86 1 L in 1 BOTTLE, PLASTIC None
2 NDC:55316-318-69 0.25 L in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 02/05/2008

Labeler - DZA Brands, LLC (090322194)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon 790752542 manufacture

Revised: 01/2011 DZA Brands, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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