Walgreens Pain Relief Gel
FDA Label NDC 0363-5061

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Company for the product Walgreens Pain Relief (NDC 0363-5061). 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

→ Active Ingredient

→ Purpose

→ Uses

→ Do Not Use

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel – 0.33oz Carton Label

→ Principal Display Panel – 0.33oz Tube Label

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, Carbomer, D&C YellowNo.10, FD&C Blue No1, FD&C Red No 40, Glycerin, Methylparaben, Propylparaben, Polyethlene Glycol, Propylene Glycol, Sodium Saccharin