Major Oral Pain Relief by Major Pharmaceuticals / Lee Pharmaceuticals / Unipack Drug Facts

Major Oral Pain Relief by

Drug Labeling and Warnings

Major Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Lee Pharmaceuticals, Unipack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAJOR ORAL PAIN RELIEF MAXIMUM STRENGTH- oral anesthetic liquid 
Major Pharmaceuticals

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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Drug Facts

Active ingredient

Benzocaine, 20%

Purpose

Oral anesthetic

Uses

Temporarily relieves pain associated with the following mouth and gum irritations:

  • toothache
  • sore gums
  • canker sores
  • braces
  • minor dental procedures
  • dentures

Warnings

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.

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a doctor or dentist

Stop use and ask a doctor or dentist 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

  • If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

  • Adults and children 2 years of age and older:
  • wipe liquid on with cotton, or cotton swab, or finger tip.
  • apply to the affected area up to 4 times daily of as directed by a doctor or dentist.
  • Children under 12 years of age: adult supervision should be given in the use of this product.
  • Children under 2 years of age: consult a doctor or dentist.

Inactive ingredients

Benzyl alcohol, D&C yellow #10, FD&C Blue #1, FD&C Red #40, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Saccharin

Major

Oral Pain Relief

Maximum Strength

Liquid Oral Anesthetic

0.5 FL OZ (15ml)

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image of label

Major

Oral Pain Relief

Maximum Strength

Liquid Oral Anesthetic

0.5 FL OZ (15ml)

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MAJOR ORAL PAIN RELIEF  MAXIMUM STRENGTH
oral anesthetic liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 00904-5899
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN (UNII: FST467XS7D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 00904-5899-41 in 1 BLISTER PACK08/01/200812/31/2018
1NDC: 00904-5899-315 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/01/200812/31/2018
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020
 
Major Pharmaceuticals