ORAL PAIN RELIEF- oral pain reliever gel 
Discount Drug Mart, 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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Drug Facts

Active ingredient (in each gram)

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

for the temporary relief of pain due to

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

Flammable: keep away from fire or flame. Avoid smoking during application and until this product has dried.

Do not use

more than directed for more than 7 days unless told to do so by a dentist or doctor

Stop use and ask a doctor if

swelling, rash or fever develops; irritation, pain or redness persists or worsens; symptoms do not improve in 7 days

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

Directions

Directions cut open tip of tube

Adults and children 2 years of age and overApply 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 ageAsk a dentist or doctor

Inactive ingredients

Inactive ingredients flavor, glycerin, polyethylene glycol, sodium saccharin, sorbic acid,

Other Information


Discount Drug Mart Oral Pain Relief

oral.carton

ORAL PAIN RELIEF 
oral pain reliever gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-996
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-996-421 in 1 CARTON11/09/2015
111.9 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 finalpart35611/09/2015
Labeler - Discount Drug Mart, Inc. (047741335)

Revised: 12/2017
Document Id: 615a4857-a67b-2852-e053-2a91aa0a53ca
Set id: 242619de-ebb9-3e4d-e054-00144ff88e88
Version: 2
Effective Time: 20171227
 
Discount Drug Mart, Inc.