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  5. Label Information: Family Care Back Pain Therapy

FDA Label for Family Care Back Pain Therapy

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. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. DOSAGE & ADMINISTRATION
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Family Care Back Pain Therapy 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 IngredientsPurpose
Camphor 80mg / patchTopical Analgesic
Menthol 24mg / patchTopical Analgesic
Capsicum Extract 16mg / patchTopical Analgesic

Otc - Purpose



Uses

For temporary relief of pains.


Warnings



Warnings

FOR EXTERNAL USE ONLY


Otc - When Using



When using this product
  • Use only as directed
  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • Do not use 1 hour prior to bathing or 30 minutes after bathing

Otc - Stop Use



Stop use and ask a doctor if
  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days

Otc - Pregnancy Or Breast Feeding



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

Otc - Keep Out Of Reach Of Children



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

Indications & Usage



Directions
  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years, consult doctor before use
  • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
    • Reseal pouch containing unused patches

Storage And Handling



Other Information

This product may cause allergic reaction in some individuals. Store in cool dry place away from direct sunlight.


Inactive Ingredient



Inactive Ingredients

Aluminium glycinate, eucalyptus oil, glycerin, kaolin, mentha oil, polysorbate 80, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, polyacrylic acid solution, sorbitol solution, hydrotalcite, water


Dosage & Administration



Distributed By:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703


MADE IN KOREA


Package Label.Principal Display Panel



image of carton label - FCBackPainTherapyPatch

image of carton label - FCBackPainTherapyPatch


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