Dologesic Roll-on Liquid
FDA Label NDC 54859-513

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division, Inc. for the product Dologesic Roll-on (NDC 54859-513). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Lidocaine HCL, USP 4% 

Otc - Purpose

Purpose

Topical Anesthetic

Indications & Usage

Use

Temporarily relieves minor pains

Warnings

Warnings

For external use only

Do not use

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

    • When using this product

    • use only as directed. Read and follow all directions and warnings on this label.
    • do not allow contact with eyes
    • do not bandage or apply local heat (such as heating pads) to the area of use.

      • Stop use and ask doctor if

      • condition worsens
      • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • Adults and children over 12 years of age
  • Apply generously to the affected area as needed every 6-8 hours, not to exceed 3 application in a 24 hour period.
  • Not for use in children under 12 years of age.

Inactive Ingredient

Inactive ingredients

camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water and xantham gum.

Otc - Questions

Questions

Llorens Pharmaceutical International Division, Inc.

Miami Fl 33147

Package Label.Principal Display Panel

Dologesicrollon (Dologesicrollon)

Dologesicrollon (Dologesicrollon)

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