Lidocaine Pain Relieving Creme
Drug Facts
Lidocaine Pain Relieving Creme
FDA Label NDC 76168-206
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 Lidocaine Pain Relieving Creme (NDC 76168-206). 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 lidocaine pain relieving creme, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine HCI 4%
Purpose
Topical anesthetic
Uses
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 the 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
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. After applying wash hands with soap and water.
children 12 years and younger: ask a doctor
Inactive Ingredients
butylated hydroxy toluene, cetomacrogol 1000, cetostearyl alcohol, cetyl alcohol, disodium EDTA, disodium hydrogen phosphate anhydrous, light liquid paraffin, propylene glycol,purified water, sorbic acid, transcutol P, white petroleum jelly.
Keep Carton As It Contains Important Information
Close cap tightly between uses.
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