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  5. Label Information: Thera Plus Pain Relief Cleansing

FDA Label for Thera Plus Pain Relief Cleansing

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. WHEN USING THIS PRODUCT
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PACKAGE LABELING:

Thera Plus Pain Relief Cleansing Product Label

The following document was submitted to the FDA by the labeler of this product Fourstar Group Usa, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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:



OuterLabel.jpg - OuterLabel

OuterLabel.jpg - OuterLabel


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