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| Product NDC Code | 55882-6102 | ||||
|---|---|---|---|---|---|
| Drug Name | Hello naturally fresh antiseptic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | MOUTHWASH | ||||
| RxCUI drug identifier | 2108024 | ||||
| Application Number | part356 | ||||
| Labeler Name | Hello Products LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 0.2%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children 12 years of age and older: rinse for 30 seconds with 20 mL (about 1 capful) twice a day. do not swallow. children 6 years to under 12 years of age: supervise use. children under 6 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients purified water, vegetable glycerin, polysorbate 80, flavor, erythritol, xylitol, poloxamer 407, citric acid, sodium benzoate, melaleuca alternifolia (tea tree) leaf oil.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use aids in the protection against oral infection.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Hello naturally fresh antiseptic Menthol, Unspecified Form MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM WATER GLYCERIN POLYSORBATE 80 ERYTHRITOL XYLITOL POLOXAMER 407 CITRIC ACID ACETATE SODIUM BENZOATE TEA TREE OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label naturally friendly ™ hello ® naturally fresh™ antiseptic mouthwash natural fresh mint with farm grown peppermint kills germs. freshens breath. rocks tastebuds. 16 FL OZ (1 PT) 473 mL 44956 Principal Display Panel - 473 mL Bottle Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Dist. by Hello Products LLC Montclair, NJ 07042
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a dentist if symptoms persist or condition worsens after regular use.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-855-444-3556
Storage and handling
Information about safe storage and handling of the drug product.Other information this rinse is not intended to replace brushing or flossing.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Ask a dentist if symptoms persist or condition worsens after regular use. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API