ORAL PAIN RELIEF- benzocaine gel

ORAL PAIN RELIEF by

Drug Labeling and Warnings

ORAL PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active ingredients

Benzocaine 20%

Purposes

Oral pain reliever

Uses

 for the temporary relief of pain due to toothaches  to help protect against infection in minor oral irritation

Warnings

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 blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:  pale, gray, or blue colored skin (cyanosis)  headache  rapid heart rate  shortness of breath  dizziness or lightheadedness  fatigue or lack of energy

Do not use  more than directed  for more than 7 days unless directed by a physician or healthcare provider

Stop use and ask a physician if  swelling, rash or fever develops  irritation, pain or redness persists or worsens  symptoms do not improve in 7 days

Keep out of reach of children. in case of overdose or allergic reaction, get medical help

Directions

Adults and children 2 years of age and over: Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider Children between 2 and 12 years of age: Should be supervised in the use of this product Children under 2 years of age: Do not use

Other information

this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted  do not use continuosly  avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive ingredients

Ammonium Glycyrrhizate, Fragrance, Polyethylene Glycol 400, Polyethylene Glycol 4000, Saccharin Sodium, Sorbic Acid, Water

SPL UNCLASSIFIED SECTION

COOLING COMFORT FORMULA

FAST COOLING
TOOTH & GUM COMFORT​

For Pain Relief & Toothaches

Mfd for and Distributed by:

Universal Distribution Center LLC
330 Applegarth Road,
Monroe Township, NJ 08831

www.universaldc.com

MADE IN CHINA

Packaging

INGREDIENTS AND APPEARANCE

ORAL PAIN RELIEF 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-443
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-443-04	1 in 1 BOX	01/20/2026
1		11.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/20/2026

Labeler - Universal Distribution Center LLC (019180459)