MEIJER MAXIMUM STRENGTH ORAL PAIN RELIEF- benzocaine, and benzalkonium chloride gel

Meijer Maximum Strength Oral Pain Relief by

Drug Labeling and Warnings

Meijer Maximum Strength Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by MEIJER DISTRIBUTION INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                           Purpose

Benzocaine 20%..............................Oral pain reliever

Benzalkonium chloride 0.1%............Antiseptic

PURPOSE

Use

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

WARNINGS

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

DO NOT USE

Do not use

• more than directed
• for more than 7 days unless directed by a physician or healthcare provider

STOP USE

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
• allergic reaction occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• cut open tip of tube on score mark
  • Adults and children 2 years of age and over: Apply a small amount of product to the cavity around gum surrounding the teeth.
  • Children under 12 years of age: Should be supervised in the use of this product
  • Children under 2 years of age: Ask a physician or healthcare provider

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

DOSAGE & ADMINISTRATION

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEIJER MAXIMUM STRENGTH ORAL PAIN RELIEF 
benzocaine, and benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-782
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-782-42	1 in 1 BOX	12/08/2016
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 not final	part356	12/08/2016

Labeler - MEIJER DISTRIBUTION INC (006959555)