QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING- benzocaine gel 
Chain Drug Marketing Association Inc

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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QC Maximum Strength Oral Analgesic 0.42oz 95362

Active ingredient Purpose

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

Uses

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

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

  • more than directed
  • for more than 7 days unless directed by a doctor
  • for teething
  • in children under 2 years of age

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

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

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

Directions

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.

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 ingredients

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

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

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in South Korea

95362

QUALITY CHOICE MAXIMUM STRENGTH ORAL PAIN RELIEVING 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-953
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-953-111 in 1 CARTON05/31/2013
111.76 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/31/2013
Labeler - Chain Drug Marketing Association Inc (011920774)

Revised: 3/2022
 
Chain Drug Marketing Association Inc