Antispetic Mouthwash
FDA Label NDC 41163-072

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Antispetic (NDC 41163-072). 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 ingredients, purpose, use, warnings, do not use, stop use and ask a dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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)

Image Description (Mm1)

Image Description (Mm1)

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