Thera Plus Pain Relief Cleansing Liquid
FDA Label NDC 80684-150

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Thera Plus Pain Relief Cleansing (NDC 80684-150). 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 ingredients, purpose, uses, warnings, when using this product, ask a doctor before use if you have, 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

Drug Facts

Active Ingredients

Benzalkonium chloride 0.13%

Lidocaine HCL 4%

Purpose

First aid antiseptic

Topical analgesic

Uses

for first aid to help prevent bacterial contamination or skin infection and for temporary relief of pain and itching associated with

  • mionr cuts
  • scrapes
  • minor burns
  • sunburn
  • minor skin irritations

Warnings

For external use only.

When Using This Product

  • do not use in or near the eyes
  • do not apply over large areas of the body or in large quantities
  • do not apply over raw surfaces or blistered areas
  • do not use longer than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites 
  • serious burns

Stop Use And Ask A Doctor If

condition worsens, or symptoms persists for more than 7 days or clear up and then occur again within a few days.

Keep Out Of Reach Of Children.

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

Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • spray a small amount of this product to affected area 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged, let dry first
  • children under 2 years of age: do not use, ask a doctor before use

Other Information

  • store at room temperature 59° - 77° F (15°- 25° C).

Inactive Ingredients

disodium EDTA, melaleuca alternifolia (tea tree) oil, octoxynol-9, propylene glycol, water

Questions Or Comments?

1-800-639-3803

Weekdays 9 AM to 4 PM EST

Package Labeling:

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