FDA Label for Good Hygiene Therapeutic Mouth Rinse

View Indications, Usage & Precautions

Good Hygiene Therapeutic Mouth Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Good Hygiene Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Active Ingredient



Active Ingredient
Hydrogen Peroxide 1.5% (w/v)


Otc - Purpose



Purposes

Oral debriding agent/oral wound cleanser


Indications & Usage



Uses
• for temporary use to cleanse canker sores and minor wounds or minor gum
inflammation resulting from minor dental procedures, dentures, orthodontic
appliances, accidental injury, or other irritations of the mouth and gums


Warnings



Warnings
Do not use this product for more than 7 days unless directed by a dentist or physician.
When using this product, do not swallow.
Stop use and ask a doctor if
• sore mouth symptoms do not improve within 7 days
• irritation, pain or redness persists or worsens
• swelling, rash or fever develops


Otc - Keep Out Of Reach Of Children



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.


Dosage & Administration



Directions
• Adults and children 2 years of age and older: rinse half capful (two teaspoons or
10 mL) around in the mouth over affected area for at least 1 minute, then spit out
• Use up to 4 times daily after meals and at bedtime or as directed by a dentist or
physician
• Children under 12 years of age should be supervised in the use of the product
• Children under 2 years of age: consult a dentist or physician


Other Safety Information



Other InformationStore at controlled room temperature 68 – 77°F (20 – 25°C)
Do not use if the safety seal is broken or missing.


Inactive Ingredient



Inactive Ingredients: Deionized water, xylitol, glycerin, natural flavor, poloxamer
407, zinc citrate, cardamom, sodium benzoate


Product Labeling



GOOD

hygiene

THERAPEUTIC
MOUTH
RINSE

mint + mint

Freshens         Whitens         Hydrates
 Breath            Teeth             Mouth

16 fl. oz.

Good Hygiene Co.
Los Angeles, CA 91352
[email protected]
Made with ♥ in the USA.

Mint + Mint

Tropical + Mint

Citrus + Mint

res


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