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Drug Facts
Good Hygiene Therapeutic Mouth Rinse
FDA Label NDC 81439-110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Good Hygiene Company for the product Good Hygiene Therapeutic Mouth Rinse (NDC 81439-110). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
81439-100 (81439 100)
Tropical + Mint
Citrus + Mint
res
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