PEROXY SHIELD MOUTH SORE- 1.5% hydrogen peroxide rinse

PEROXY SHIELD MOUTH SORE by

Drug Labeling and Warnings

PEROXY SHIELD MOUTH SORE by is a Otc medication manufactured, distributed, or labeled by Dental Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrogen peroxide 1.5% (w/w)

Purpose(s)

Oral debriding agent/oral wound cleaner

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 your dentist or physician.

Warnings

When using this product, do not swallow.

Warnings

Stop use and ask your doctor if:

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

Warnings

Keep out of reach of children.

• Children under 12 years of age: consult a dentist of physician.
• Children under 12 years of age should be supervised in the use of the product.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• For adults and children under 2 years of age or older: rinse 10mL around in the mouth over the 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.

Other information

• Store at controlled room temperature, 20-25°C (68-77°F) and away from direct sunlight.
• For your protection, do not use if tamper evident seal under the cap is damaged or missing.

Inactive ingredients

FD&C Blue #1, Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Propylene Glycol, Sodium Saccharin, Sorbitol, Sucralose, Water

Questions or comments?

Call 1-800-835-0885

Principal Display Panel

ALCOHOL FREE

PEROXY SHIELD®

1.5% HYDROGEN PEROXIDE

MOUTH SORE RINSE

HELPS PROMOTE

A CLEANER MOUTH & HEALING OF

• ORAL SORES
• IRRITATIONS
• MOUTH BURNS

MINT FLAVOR

REF. 035-0101-002

63.0 FL. OZ. (1863 mL)

INGREDIENTS AND APPEARANCE

PEROXY SHIELD MOUTH SORE 
1.5% hydrogen peroxide rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55346-3501
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 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55346-3501-1	1863 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/12/2020
2	NDC: 55346-3501-2	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	06/03/2020

Labeler - Dental Technologies, Inc. (148312838)

Registrant - Dental Technologies, Inc. (148312838)

Establishment
Name	Address	ID/FEI	Business Operations
Dental Technologies, Inc.		148312838	manufacture(55346-3501) , pack(55346-3501) , label(55346-3501)