1. Home
  2. Labeler Index
  3. United Exchange Corp
  4. 65923-700
  5. Label Information: Pain Relief Therapy Patch

FDA Label for Pain Relief Therapy Patch

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - WHEN USING
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INDICATIONS & USAGE
    9. INACTIVE INGREDIENT
    10. DOSAGE & ADMINISTRATION
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relief Therapy Patch Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange Corp. 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.

Otc - Active Ingredient



Active ingredient                                                               Purpose

Menthol 5% .....................................................................Topical analgesic


Otc - Purpose



Uses temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings



Warnings

For external use only


Otc - When Using



When using this product:

  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Otc - Stop 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
  • redness is present
  • skin irritation develops

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


Indications & Usage



Directions

adults and children 12 years of age and older:

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used up to 8 hours
  • should be used no more than 3 times a day
    • children under 12 years of age:
    • consult a doctor

Inactive Ingredient



Inactive ingredients: Aloe Barbadensis Leaf Juice, Aluminum Hydroxide, Disodium EDTA, Gelatin, Kaolin, Methylparaben, Glycerin, Titanium Dioxide, Isopropyl Myristate, Purified Water,

Polyvinyl Pyrrolidone, Peg-4 Stearate, Polyvinyl Alcohol, Polysorbate 80, PVP, Tocopherol Acetate, Alumino Magnesium Metasilicate, Castor Oil, Tartaric Acid, BHT, Sodium Polyacrylate.


Dosage & Administration



Distributed by:

UNITED EXCHANGE CORP

17211 Valley View Ave.

Cerritos, CA 90703 USA

MADE IN KOREA


Package Label.Principal Display Panel



image of carton label - PainReliefTherapyPatch

image of carton label - PainReliefTherapyPatch


* Please review the disclaimer below.