Other
TheraBreath Healthy Gums + Deep Clean Variety Pack
Therabreath Deep Clean Fresh Mint Rinse
FDA Label NDC 10237-261
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Therabreath Deep Clean Fresh Mint (NDC 10237-261). 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 other, drug facts, active ingredient, purpose, uses, warnings, stop use and ask a dentist if, keep out of reach of children under 6 years of age., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts
TheraBreath Healthy Gums Oral Rinse
TheraBreath Deep Clean Oral Rinse
Active Ingredient
Cetylpyridinium chloride 0.05%
Cetylpyridinium chloride 0.1%
Purpose
Antigingivitis/Antiplaque
Antigingivitis/Antiplaque
Uses
- helps prevent • gingivitis, an early form of gum disease • bleeding gums
- helps control plaque that leads to • gingivitus • bleeding gums
helps prevent • gingivitis, an early form of gum disease • bleeding gums
helps control plaque that leads to • gingivitus • bleeding gums
Warnings
Warnings
Warnings
Stop Use And Ask A Dentist If
- 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 teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
- 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 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 right away.
Directions
| adults and children 12 years and older | vigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow rinse. |
| children 6 years to under 12 years | supervise use |
| children under 6 years | do not use |
| adults and children 12 years and older | vigorously swish 20 milliliters (4 teaspoonfuls) 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 | supervise use |
| children under 6 years | do not use |
Other Information
- this rinse is not intended to replace brushing or flossing
- this rinse is not intended to replace brushing or flossing
do not use both oral rinses together.
do not use both oral rinses together.
Inactive Ingredients
water, glycerin, poloxamer 407, flavor, sucralose
water, glycerin, poloxamer 407, flavor, sucralose
Otc - Questions
Church & Dwight Co., Inc.
PHONE: 1-800-973-7374
WEB: THERABREATH.COM
Church & Dwight Co., Inc.
PHONE: 1-800-973-7374
WEB: THERABREATH.COM
Keep Out Of Reachof Children Under 6 Years Of Age.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel
TheraBreath TM
HEALTHY GUMS + DEEP CLEAN
ANTIGINGIVITIS/ANTIPLAQUE VARIETY PACK
Add TheraBreath to your swishy time routine for healthy gums or a deep clean
Helps fight gingivitis for 12 hours
Kills 99.9% of germs that cause bad breath, plaque & gingivitis*
*in laboratory tests
TheraBreath HEALTHY GUMS CLEAN MINT
TheraBreath DEEP CLEAN FRESH MINT
2 BOTTLES 16 FL OZ (1 PT) 473 mL each; 32 FL OZ (1 qt) 946 mL TOTAL
* Please review the disclaimer below.
