GOOD HYGIENE THERAPEUTIC MOUTH RINSE- hydrogen peroxide debriding agent liquid

Good Hygiene Therapeutic Mouth Rinse by

Drug Labeling and Warnings

Good Hygiene Therapeutic Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by Good Hygiene Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient
Hydrogen Peroxide 1.5% (w/v)

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

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
practice@goodhygiene.com
Made with ♥ in the USA.

Mint + Mint

Tropical + Mint

Citrus + Mint

res

INGREDIENTS AND APPEARANCE

GOOD HYGIENE THERAPEUTIC MOUTH RINSE 
hydrogen peroxide debriding agent liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81439-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
ZINC CITRATE (UNII: K72I3DEX9B)
CARDAMOM (UNII: 8BC4CUT4JL)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81439-100-16	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/01/2021	05/12/2023

GOOD HYGIENE THERAPEUTIC MOUTH RINSE 
hydrogen peroxide debriding agent liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81439-110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
ZINC CITRATE (UNII: K72I3DEX9B)
CARDAMOM (UNII: 8BC4CUT4JL)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81439-110-16	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/01/2021

GOOD HYGIENE THERAPEUTIC MOUTH RINSE 
hydrogen peroxide debriding agent liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81439-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
ZINC CITRATE (UNII: K72I3DEX9B)
CARDAMOM (UNII: 8BC4CUT4JL)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81439-120-16	475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/01/2021

Labeler - Good Hygiene Company (131413215)

Registrant - Good Hygiene Company (131413215)