ANESTHETIC- benzocaine gel
Moore Medical LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Moore Medical Orasol Gel

Drug Facts

Active Ingredient (in each gram)

Benzocaine 20.0% (w/w)

Purpose

Oral anesthetic

Uses

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

Warnings

For oral use only.

Do not exceed recommended dosage.

Methemoglobinemia warning:

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

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

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

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

avoid contact with eyes

Keep out of reach of children

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

Directions

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

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

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

Questions or Comments?

Call 800.234.1464

Moore Medical Orasol Gel 20% Label

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

ANESTHETIC
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55670-810
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
PEPPERMINT OIL (UNII: AV092KU4JH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55670-810-01	75 in 1 BOX	07/12/2012	05/31/2024
1		0.75 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/12/2012	05/31/2024

Labeler - Moore Medical LLC (051420107)

Registrant - Unifirts First Aid Corporation (832947092)

Revised: 10/2022

Document Id: ebdd6f2f-3c81-3513-e053-2995a90ae0e8

Set id: 6ea8daf0-24c5-4670-b8a2-0b82f47780ec

Version: 9

Effective Time: 20221025

Moore Medical LLC