Moore Medical Orasol Gel

Manufacturer: Moore Medical LLC | Unifirts First Aid Corporation
Effective date: 2022-10-25
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: legacy-cache
Hydrated at: 2026-08-01 21:50:54

Label at a glance#

ProductAnesthetic

Active ingredientBENZOCAINE

Label structure9 sections

Indications and uses

For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Dosage and administration

Adults and children( 2 years and older): dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor. Children under 2 years of age: Do not use

Contacts and useful links#

PhoneLabel contact800.234.1464

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20.0% (w/w)

Purpose

OTC - PURPOSE SECTION

Oral anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Warnings

WARNINGS SECTION

For oral use only.

Do not exceed recommended dosage.

Methemoglobinemia warning:

SPL UNCLASSIFIED SECTION

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before.

Stop use and seek medical attention if you or a child in your care develops:

pale, gray or blue colored skin (cyanosis)
rapid heart rate
dizziness or lightheadedness
headache
shortness of breath
fatigue or lack of energy

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use this product if you have a history of allergy to local anesthetics, such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occrs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

for teething - any teething related indication will not be ab appropriate use of this product
in children under 2 years of age
for more than 7 days unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

sore mouth does not improve in 7 days
irritation, pain, or redness persists or worsens
swelling, rash, fever or other allergic reaction develops

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children( 2 years and older):

dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.

Children under 2 years of age:

Do not use

Other Information

SPL UNCLASSIFIED SECTION

Do not use if packet is torn, cut, or opened
Store at room temperature, 59° to 86°F (15° to 30°C)
tamper evident sealed packets

Inactive Ingredients

INACTIVE INGREDIENT SECTION

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

Questions or Comments?

OTC - QUESTIONS SECTION

Call 800.234.1464

Moore Medical Orasol Gel 20% Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mooremedical
Supporting Health & Care

Reorder No. 82474
UPN# 0-0607415-82474-2

MooreBrand®
Orasol Gel 20%
75 Packets
Each Packet Net. Wt. 0.75gm

Temporary relief of minor pain
and sore mouth.

Distributed by:

Moore Medical LLC

Farmington, CT 06032

Manufacturer 21305178

Made in India and USA

Moore Medical

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	4
benzocaine	ACTIVE MOIETY	U3RSY48JW5	4
peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	4
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	4
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	4
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	4
sorbic acid	INACTIVE INGREDIENT	X045WJ989B	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Anesthetic
benzocaine
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
PEPPERMINT OIL
SACCHARIN SODIUM
SORBIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55670-810	55670-810-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBIC ACID	X045WJ989B	IACT
BENZOCAINE	U3RSY48JW5	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 138 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / SOFT TISSUE		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRASYNOVIAL	3 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET, FILM COATED / ORAL		5 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	GEL / TOPICAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION / INTRAVENOUS	0.5 ml		Exact identifier — unii candidate 28 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, CHEWABLE / ORAL	15 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SPRAY, METERED / NASAL		96 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUPPOSITORY / RECTAL		5704 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	CREAM / TOPICAL		396 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	SPRAY, METERED / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, EXTENDED RELEASE / ORAL		61 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, LIQUID FILLED / ORAL		1122 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	SUSPENSION, EXTENDED RELEASE / ORAL		37 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAMUSCULAR	20.3 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / TOPICAL		6300 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	CONCENTRATE / ORAL	0.05 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, DELAYED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	SOLUTION/ DROPS / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	POWDER / SUBLINGUAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / SUBCUTANEOUS	2.88 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
peppermint oil	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAVENOUS		24186 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SWAB / TOPICAL		5250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
sorbic acid	SORBIC ACID	X045WJ989B	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	G2M7P15E5P	INJECTION, SUSPENSION / INTRALESIONAL		87 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / RECTAL	0.25 mg/mg		Exact identifier — unii candidate 36 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ebdd6f2f-3c81-3513-e053-2995a90ae0e8			6ea8daf0-24c5-4670-b8a2-0b82f47780ec	2022-10-25	Warnings	Exact identifier spl id: ebdd6f2f-3c81-3513-e053-2995a90ae0e8 spl set id: 6ea8daf0-24c5-4670-b8a2-0b82f47780ec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.