EQUATE ORAL PAIN RELIEF- benzocaine gel 
Sheffield Pharmaceuticals LLC

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 Pain Reliever

Uses

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

  • 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

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

Directions

Other information

Inactive ingredients

Benzyl Alcohol, Carboer, D&C Yellow No10, FD&C Blue No1, FD&C Red No40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

Principal Display Panel – 0.33oz Carton Label

NDC 11527-081-28

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20% NET WT. 0.33 OZ (9.35g)

Principal Display Panel – 0.33oz Carton Label

Principal Display Panel – 0.33oz Carton Label

Principal Display Panel – 0.33oz Tube Label

NDC 11527-081-28

Oral Pain Relief

MAXIMUM STRENGTH GEL

Benzocaine 20%

The Adult Medicine for Toothache

Fast Toothache Pain Reliever

NET WT. 0.33 OZ (9.35g)

Principal Display Panel – 0.33oz Tube Label

Principal Display Panel – 0.33oz Tube Label
EQUATE ORAL PAIN RELIEF 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-081
Route of AdministrationORAL
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 300 (UNII: 5655G9Y8AQ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER 934 (UNII: Z135WT9208)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorSPEARMINT (SPEARMINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-081-281 in 1 CARTON01/23/200712/31/2023
19.35 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 finalpart35601/23/2007
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-081)

Revised: 8/2020
Document Id: 1d3bffdc-28d0-4a4b-a5fe-76fec10ab7f8
Set id: 53cbac1e-0382-4e03-80fb-f13bcae2b3dd
Version: 2
Effective Time: 20200818
 
Sheffield Pharmaceuticals LLC