Rite Aid Lidocaine Roll On
FDA Label NDC 76168-307

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma Llc for the product Rite Aid Lidocaine Roll On (NDC 76168-307). 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, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine HCl 4%

Purpose

Topical anesthetic

Use

temporarily relieves minor pain

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 carton.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to area of use

Stop Use And Ask A Doctor If

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

    • Flammable

    • keep away from fire or flame

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children And Pets.

If swallowed, get medical help or contact a Poison

Control Center right away.

Directions

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

    • children 12 years or younger: ask a doctor

Inactive Ingredients

aloe vera gel, dimethicone, disodium EDTA, ethylhexylglycerin, methylparaben, C10-30 alkyl acrylate cross polymer, polysorbate 60, SD alcohol 40 (15%), triethanolamine, water

Child-resistant packaging. Close cap tightly after use. Keep carton as it contains important information.

Principal Display Panel

Pain-relieving-roll-on_2.5-floz (Pain Relieving Roll On 2.5 Floz)

Pain-relieving-roll-on_2.5-floz (Pain Relieving Roll On 2.5 Floz)

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