Equate Oral Pain Relief
FDA Label NDC 11527-081

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product Equate Oral Pain Relief (NDC 11527-081). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, do not use, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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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