ORAL PAIN RELIEF- benzocaine gel 
GERI-CARE PHARMACEUTICAL CORP

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ORAL PAIN RELIEF

Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Uses

temporary relieves pain associated with the following mouth
and gum irritations: • toothache • sore gums • canker
sores • braces • minor dental procedures • dentures

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

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 occurs, stop use and seek medical help right away.

Do not use

• for teething

• in children under 2 years of age

• more than recommended
• for more than 7 days unless told to do so by a dentist or doctor

When using this product

• avoid contact with the eyes

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days

• irritation, pain, or redness persists or worsens

• swelling, rash or fever develops

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not exceed recommended dosage

• do not use for more than 7 days unless told to do so by a dentist or doctor

• adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist
• children between 2 and 12 years of age: adult supervision should be given in use of this product
• children under 2 years of age: do not use

Other information

• do not use tube if it is cut prior to opening

• to open tube, cut open tip of tube on score mark with scissors
• store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive ingredients

Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic Acid

Questions or Comments?

1-800-540-3765

1

ORAL PAIN RELIEF 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-139
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-139-051 in 1 CARTON03/01/2021
114.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02203/01/2021
Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)
Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)

Revised: 10/2023
Document Id: 0904e5d4-6c9c-156d-e063-6294a90a4a7d
Set id: d294a39e-55f4-272d-e053-2995a90ab7f7
Version: 2
Effective Time: 20231031
 
GERI-CARE PHARMACEUTICAL CORP