QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING- benzocaine gel

Quality Choice Maximum Strength Oral Pain Relieving by

Drug Labeling and Warnings

Quality Choice Maximum Strength Oral Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

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

PURPOSE

Uses

• temporarily relieves pain due to:
• toothache
• canker sores
• gum pain
• denture pain
• cheek bites

WARNINGS

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 your child has 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 doctor
• for teething
• in children under 2 years of age

STOP USE

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
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding , ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

• Adults and children 2 years of age and older.:

  Remove cap and cut tip of tube. 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 dentist or doctor.

• Children under 12 years of age.: Should be supervised in the use of this product.
• Children under 2 years of age.: Do not use.

STORAGE AND HANDLING

Other information

• store at room temperature 20° to 25°C (68° to 77°F)
• this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted
• do not use continuously
  

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

Distributed By C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in South Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-953
Route of Administration	TOPICAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-953-11	1 in 1 CARTON	05/31/2013
1		11.76 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	05/31/2013

Labeler - Chain Drug Marketing Association Inc (011920774)