THE NATURAL DENTIST RINSE- hydrogen peroxide rinse

The Natural Dentist by

Drug Labeling and Warnings

The Natural Dentist by is a Otc medication manufactured, distributed, or labeled by Caldwell Consumer Health LLC, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrogen Peroxide 1.5%...............Oral Debriding Agent, Oral Wound Cleanser

Uses

Use in cleansing minor wound or minor gum inflamationresulting from

• minor dental procedures
• orthodontic procedure
• Dentures
• Accidental injury
• Canker sores
• Other irritations of the mouth and gums
• Aids in the removal of Phlegm, mucus, other secretions associated with sore mouth

WARNINGS

Do not use this product more than 7 days unless directed by a dentist or healthcare provider. When using this product do not swallow. Do not exceed recommended dosage. Stop use and see your physician promptly if:

• Swelling, rash or fever develops
• Irritation, pain or redness persists or worsens
• Sore mouth symptoms do not improve in 7 days

Do not use is safety seal is broken or missing

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.

Directions

Ready to use, no mixing needed. Adults and children 2 years of age and older:​ Swish 2 teaspoons or 10mL around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed ny a dentist or healthcare provider. Children under 12 years of age:​ Should be supervised in the use of this product. Children under 2 years of age: Consult a Dentist or healthcare provider.

DOSAGE & ADMINISTRATION

Adults and children 2 years of age and older: Swish 2 teaspoons or 10mL around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed ny a dentist or healthcare provider.

Other Information

To remove child resistant cap push down and turn. Close cap tightly when not in use.

Store at room temperature 68°-77°F (20°-25°C).

Keep away from heat or direct sunlight.

Inactive ingredients

Inactive Ingredients: Water, Glycerin, Aloe Vera Gel, Xylitol, Polysorbate 80, Flavor.

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

THE NATURAL DENTIST  RINSE
hydrogen peroxide rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34362-0510
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.15 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color		Score
Shape		Size
Flavor	WINTERGREEN (wintergreen)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34362-0510-2	1 in 1 CARTON	12/01/2015
1	NDC: 34362-0510-1	236 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/01/2015

Labeler - Caldwell Consumer Health LLC (828558713)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	manufacture(34362-0510) , pack(34362-0510)