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NDC 00363-1045-43 Oral Sore Antiseptic 1.5; 1 mg/mL; mg/mL Details

Oral Sore Antiseptic 1.5; 1 mg/mL; mg/mL

Oral Sore Antiseptic is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is HYDROGEN PEROXIDE; MENTHOL.

Product Information

NDC	00363-1045
Product ID	0363-1045_0b413dfe-ee12-4204-8ff7-f10d693860f4
Associated GPIs
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	Oral Sore Antiseptic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrogen Peroxide, Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	1.5; 1
Active Ingredient Units	mg/mL; mg/mL
Substance Name	HYDROGEN PEROXIDE; MENTHOL
Labeler Name	Walgreens
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 00363-1045-43 (00363104543)

Pricing Information	N/A
NDC Package Code	0363-1045-43
Billing NDC	00363104543
Package	473 mL in 1 BOTTLE, PLASTIC (0363-1045-43)
Marketing Start Date	2020-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 55807b18-42ed-45a7-845e-fcf7f5d70d04 Details

active ingredients

Hydrogen peroxide 1.5% (w/v)

Menthol 0.1% (w/v)

purpose

Oral debriding agent/Oral antiseptic

Oral pain reliever

uses

▪ first aid to help protect against bacterial contamination in minor oral wounds

▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures ▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores

▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouthUses

▪ first aid to help protect against bacterial contamination in minor oral wounds

▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures

▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores

▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouth

warnings

Stop use and ask a doctor if

▪ sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting

▪ irritation, pain, or redness persists or worsens

▪ swelling, rash, or fever develops

▪ sore mouth symptoms do not improve in 7 days

When using this product

do not swallow
do not use more than 7 days unless directed by a dentist or doctor
do not exceed recommended dosage

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

directions

Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily 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 doctor

other information

store at controlled room temperature 68-77°F (20-25°C)
keep away from heat or direct sunlight

inactive ingredients

alcohol (4.1% v/v), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

SAFETY SEAL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

questions

Call 1-800-925-4733

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED walgreens.com

MADE IN U.S.A. WITH U.S. AND FOREIGN COMPONENTS

Our pharmacist recommend the Walgreens brand. We invite you to compare to national brands.

This product is not manufacted or distributed by

Church & Dwight Co., Inc owner of the trademark Orajel

Principal display panel

Walgreens

WALGREENS - PHARMACIST RECOMMENDED

Compare to the active ingredients in Orael Antiseptic Rinse

Antiseptic

Rinse

ORAL PAIN RELIEVER & DEBRIDING AGEN WITH HYDROGEN PEROXIDE & MENTHOL

Cleans Mouth Sores

For mouth sores, including gum irritation from braces or dentures & canker sores
Temporary pain relief for mouth sores
Kills germs & bacterial

Mint flavor

16 FL OZ (473 mL)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

INGREDIENTS AND APPEARANCE

ORAL SORE ANTISEPTIC

hydrogen peroxide, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-1045
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLOXAMER 338 (UNII: F75JV2T505)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-1045-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	03/15/2020

Labeler - Walgreens (008965063)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
VI-Jon, LLC		790752542	manufacture(0363-1045)

Name	Address	ID/FEI	Business Operations
Establishment
VI-Jon, LLC		088520668	manufacture(0363-1045)

Revised: 9/2022

Document Id: 0b413dfe-ee12-4204-8ff7-f10d693860f4

Set id: 55807b18-42ed-45a7-845e-fcf7f5d70d04

Version: 14

Effective Time: 20220902