Active Ingredient
Eucalyptol (0.092%)
Menthol (0.042%)
Methyl Salicylate (0.060%)
Thymol (0.064%)
Antiseptic Liquid
FDA Label NDC 55319-290
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Antiseptic (NDC 55319-290). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purposes, uses, do not use, stop use and ask a dentist, keep out of reach of children under 6 years of age, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antiplaque/antigingivitis
Uses
helps prevent and reduce
- plaque
- gingivitis
Do Not Use
in children under 12 years of age.
Stop Use And Ask A Dentist
- gingivitis, bleeding, or redness persists for more than 2 weeks
- you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out Of Reach Of Children Under 6 Years Of Age
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
- adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
- children 6 years to under 12 years of age: supervise use
- children under 6 years of age: do not use
Other Information
- store at room temperature
- cold weather may cloud this product. Its antiseptic properties are not affected.
- this rinse is not intended to replace brushing or flossing
Inactive Ingredients
water, alcohol (21.6% v/v), sorbitol, poloxamer 407, sodium benzoate, benzoic acid, sodium saccharin, flavor, D&C yellow #10, FD&C green #3
Questions Or Comments
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*Compare to the active ingredient in Listerine® Freshburst®
Antiseptic
Mouthwash
Eucalyptol (0.092%)
Menthol (0.042%)
Methyl salicylate (0.060%)
Thymol (0.064%)
Antiplaque/antigingivitis
Kill germs that cause plaque, gingivitis, bad breath
Helps to control and prevent plaque that leads to gingivitis
GREEN MINT
L (QT PT FL OZ)
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Listerine® Freshburst®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
Package Label
FAMILY WELLNESS Antiseptic Mouthwash Green Mint
* Please review the disclaimer below.
