Theracare Lidocaine Pain Relief Spray
FDA Label NDC 71101-941

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Lidocaine Pain Relief (NDC 71101-941). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Lidocaine 4%

Purpose

Pain relieving spray

Uses

Uses For the temporary relief of minor aches and pain associated with

• minor burns

  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
  • rashes due to poison ivy, poison oak or poison sumac

Warnings

For external use only.

Flammable.Keep away from fire or flame. Do not use while smoking.  Do not punture or incinerate. Contents under pressure 

When Using This Product

When using this product

  • Avoid contact with eyes. 
  •  do not use in large quatities, particularly over raw surfaces or blistered areas

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

If Pregnant Or Breastfeeding

Ask a helth professional before use

Directions

Adults and children 2 years or older:Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, ask a doctor.

Other Information

Store out of direct sunlight, in a cool dry, well-ventilated area.  Do not store at temperature above 120F (49C)

Inactive Ingredients

caprylic/capric triglyceride, propylene glycol, SD alcohol, water

Questions Or Comments?

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