FDA Label for Antispetic
View Indications, Usage & Precautions
Antispetic Product Label
The following document was submitted to the FDA by the labeler of this product United Natural Foods, Inc. Dba Unfi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Eucalyptol 0.092%
Menthol 0.042%
Methyl salicylate 0.060%
Thymol 0.064%
Purpose
Antigingivitis, antiplaque
Use
help control plaque that leads to gingivitis
Warnings
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 - 77⁰ F)
Inactive Ingredients
water, alcohol 21.6%, sorbitol solution, flavoring, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3
Tep
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION.
Ada Council On Scientific Affairs
The ADA Council on Scientific Affairs' Acceptance of Equaline Spring Mint antiseptic Mouth rinse is based on its finding tha the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.
Disclaimer
This product is not manufatured or distriubted by Johnson & Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.
Adverse Reactions
DISTRIBUTED BY SUPERVALU INC
EDEN PRAIRIE, MN 55344 USA
Contact us at 1-877-932-7948
or www.supervalu-ourownbrands.com
072.002/072AL
Principal Display Panel
compare to
Listerine FreshBurst
Antiseptic Mouthwash
active ingredient
EQUALINE
antispetic
mouthrinse
antigingivitis/antiplaque
ADA
Accepted
Amnerican
Dental
Association
Kills germs that cause bad breath, plaque and gingivitis gum disease
spring mint
1 L (33.8 FL OZ)
* Please review the disclaimer below.