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NDC 53462-0075-60 Perox-A-Mint Solution 15 mg/mL Details

Perox-A-Mint Solution 15 mg/mL

Perox-A-Mint Solution is a BUCCAL MOUTHWASH in the HUMAN OTC DRUG category. It is labeled and distributed by Sage Products, LLC. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	53462-0075
Product ID	53462-075_dc8c9b6d-4de0-18e0-e053-2a95a90a7353
Associated GPIs	88100033002010
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Perox-A-Mint Solution
Proprietary Name Suffix	n/a
Non-Proprietary Name	HYDROGEN PEROXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	MOUTHWASH
Route	BUCCAL
Active Ingredient Strength	15
Active Ingredient Units	mg/mL
Substance Name	HYDROGEN PEROXIDE
Labeler Name	Sage Products, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 53462-0075-60 (53462007560)

Pricing Information	N/A
NDC Package Code	53462-075-60
Billing NDC	53462007560
Package	7 mL in 1 PACKET (53462-075-60)
Marketing Start Date	1998-05-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 50823ff5-ad08-4449-bc4a-9a8ae25ec0d5 Details

Active ingredient

Hydrogen Peroxide 1.5%

Purpose

Oral Debriding Agent

Use

Aids in the removal of secretions associated with sore mouth

Warnings

Do not use:

For more than 7 days unless told to do so by a doctor.
Avoid swallowing.

Stop use and ask a doctor if:

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

Keep out of reach of children. If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use up to 4 times daily or as directed by a dentist or doctor.
Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.
Children under 12 years of age: supervise use.
Children under 3 years of age: consult a dentist or doctor.

Inactive Ingredients

Blue 1 (CI42090), menthol flavor, phosphoric acid, polysorbate 80, sodium saccharin, Water, Yellow 6 (CI15985)

SPL UNCLASSIFIED SECTION

Questions? Call toll free 800-323-2220

Perox-A-Mint Solution

INGREDIENTS AND APPEARANCE

PEROX-A-MINT SOLUTION

hydrogen peroxide mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53462-075
Route of Administration	BUCCAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53462-075-30	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/1998
2	NDC:53462-075-40	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/1998
3	NDC:53462-075-60	7 mL in 1 PACKET; Type 0: Not a Combination Product	05/21/1998

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	05/21/1998

Labeler - Sage Products, LLC (054326178)

Registrant - Sage Products, LLC (054326178)

Revised: 4/2022

Document Id: dc8c9b6d-4de0-18e0-e053-2a95a90a7353

Set id: 50823ff5-ad08-4449-bc4a-9a8ae25ec0d5

Version: 10

Effective Time: 20220413