EQUATE ORAL PAIN RELIEF- benzocaine gel

Equate Oral Pain Relief by

Drug Labeling and Warnings

Equate Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

• temporary relief of occasional minor irritation, pain and sore mouth

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

• do not use tube if it is cut prior to opening
• cut open tip of tube on score mark
• use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
• apply to affected area up to four times daily or as directed by a dentist or physician
• Adults and children 2 years of age and older: Apply to affected area
• Children under 12 years of age should be supervised in the use of this product
• Children under 2 years of age: Consult a doctor

Other information

• store at a controlled room temperature 59°-86°F (15°-30°C)

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 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)

INGREDIENTS AND APPEARANCE

EQUATE ORAL PAIN RELIEF 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-081
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score
Shape		Size
Flavor	SPEARMINT (SPEARMINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-081-28	1 in 1 CARTON	01/23/2007
1		9.35 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	01/23/2007

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(11527-081)