ORAL PAIN RELIEF GEL- benzocaine 20% gel

Oral Pain Relief Gel by

Drug Labeling and Warnings

Oral Pain Relief Gel by is a Otc medication manufactured, distributed, or labeled by Sled Distribution, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzocaine 20% (w/w)

PURPOSE

Purpose

Oral anesthetic

INDICATIONS & USAGE

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

Warnings

For oral use only.

DO NOT USE

stop use and ask a doctor if get any discomfort.

STOP USE

Stop use and ask a dentist or 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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

Inactive ingredients

Polyethylene Glycol, Fragrance

PRINCIPAL DISPLAY PANEL

Benzocaine 20% | Oral Anesthetic

NET WT 0.75 g

INGREDIENTS AND APPEARANCE

ORAL PAIN RELIEF GEL 
benzocaine 20% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81417-121
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81417-121-01	1 in 1 PACKAGE	03/25/2022
1		0.75 g in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/25/2022

Labeler - Sled Distribution, LLC (079772888)

Establishment
Name	Address	ID/FEI	Business Operations
Sled Distribution, LLC		079772888	manufacture(81417-121)