FDA Label for Equate Oral Pain Relief

View Indications, Usage & Precautions

Equate Oral Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Sheffield Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

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.


Active Ingredient



Benzocaine 20%


Purpose



Oral Pain Reliever


Uses



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

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

Otc - Keep Out Of Reach Of Children



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)


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