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)

label image

Major

Oral Pain Relief

Maximum Strength

Liquid Oral Anesthetic

0.5 FL OZ (15ml)

card image

MAJOR ORAL PAIN RELIEF  MAXIMUM STRENGTH
oral anesthetic liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 00904-5899
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 00904-5899-4	1 in 1 BLISTER PACK	08/01/2008	12/31/2018
1	NDC: 00904-5899-3	15 mL in 1 BOTTLE, GLASS; 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	08/01/2008	12/31/2018

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020

Document Id: 209a1af2-e230-423f-82ec-50d54a98bfb6

34390-5

Set id: f659c896-815e-4c58-8fa7-f1356955973e

Version: 5

Effective Time: 20200117

 

Major Pharmaceuticals