Analgesic
FDA Label NDC 72663-500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Welly Health Pbc for the product Analgesic (NDC 72663-500). 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 active ingredient, purpose, uses, otc - keep out of reach of children, do not use, stop use, ask a doctor, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Lidocaine

HCl 2.0%

Purpose

Topical

pain relief

Uses

Temporary pain relief for minor burns

Otc - Keep Out Of Reach Of Children

External use only. Keep out of reach of children.

Do Not Use

  • near eyes, if this happens, rinse thoroughly with water
  • in large quantities, particularly over raw or blistered areas

Stop Use, Ask A Doctor

  • if conditions worsen or last more than 7 days or clears up and returns. If ingested contact a Poison Control Center directly

Directions

  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 2: do not use, ask a doctor

Inactive Ingredients

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Principal Display Panel - Welly Health Burn Gel Pouch Label

Welly™

Burn Gel

0.9/ 1/32 OZ

Principal Display Panel (Welly Health Burn Gel Pouch Label)

Principal Display Panel (Welly Health Burn Gel Pouch Label)

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