Good Hygiene Therapeutic Mouth Rinse

Good Hygiene Therapeutic Mouth Rinse
SPL v3
SPL
SPL Set ID 9139b1af-3389-44af-8699-0011843bc6d0
Route
ORAL
Published
Effective Date 2021-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (1.5 g)
Inactive Ingredients
Water Xylitol Glycerin Poloxamer 407 Zinc Citrate Cardamom Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-05-01 Until 2023-05-12

Description

Drug Facts


Medication Information

Warnings and Precautions

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

Indications and 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

Dosage and 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 51727-6

Inactive Ingredients: Deionized water, xylitol, glycerin, natural flavor, poloxamer

407, zinc citrate, cardamom, sodium benzoate

Section 55105-1

Purposes

Oral debriding agent/oral wound cleanser

Section 55106-9

Active Ingredient

Hydrogen Peroxide 1.5% (w/v)

Section 60561-8

Other Information Store at controlled room temperature 68 – 77°F (20 – 25°C)

Do not use if the safety seal is broken or missing.

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


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

Inactive Ingredients: Deionized water, xylitol, glycerin, natural flavor, poloxamer

407, zinc citrate, cardamom, sodium benzoate

Section 55105-1 (55105-1)

Purposes

Oral debriding agent/oral wound cleanser

Section 55106-9 (55106-9)

Active Ingredient

Hydrogen Peroxide 1.5% (w/v)

Section 60561-8 (60561-8)

Other Information Store at controlled room temperature 68 – 77°F (20 – 25°C)

Do not use if the safety seal is broken or missing.

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


Advanced Ingredient Data


Raw Label Data

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