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Dist. by Colgate-Palmolive Co.
New York, NY 10022
Hello Extra Minty Mouthwash
FDA Label NDC 35000-511
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Colgate-palmolive Company for the product Hello Extra Minty (NDC 35000-511). 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, active ingredient, purpose, uses, stop use and ask a dentist if, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Cetylpyridinium Chloride 0.075%
Purpose
Antigingivitis/Antiplaque
Uses
- helps prevent and reduce plaque and gingivitis
- helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums
Stop Use And Ask A Dentist If
- gingivitis, bleeding, or redness persist for more than two 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.
Otc - Keep Out Of Reach Of Children
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 Poison Control Center right away.
Directions
| adults and children 12 years of age and older | vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds, 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
- this rinse is not intended to replace brushing or flossing.
Inactive Ingredients
water, glycerin, aloe barbadensis leaf, polysorbate 80, erythritol, xylitol, poloxamer 407, flavor, cocos nucifera (coconut) oil, sodium benzoate, citric acid, melaleuca alternifolia (tea tree) leaf oil, rebaudioside a.
Questions?
1-855-444-3556
Principal Display Panel - 520 Ml Bottle Label
hello®
extra minty
antigingivitis/antiplaque mouthwash
with extra cooling
no alcohol • no fluoride • no dyes
made with farm grown mint
17.6 FL OZ (1.1 PT) 520 mL
PS0086078
Principal Display Panel (520 mL Bottle Label)
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