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  5. Label Information: Assured Cold N Hot Pain Relief Menthol

FDA Label for Assured Cold N Hot Pain Relief Menthol

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. INDICATIONS & USAGE
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. DOSAGE & ADMINISTRATION
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Assured Cold N Hot Pain Relief Menthol Product Label

The following document was submitted to the FDA by the labeler of this product Greenbrier International, 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.

Otc - Active Ingredient



Active Ingredient                                                                     Purpose

Menthol 5%--------------------------------------------------------- Topical analgestic


Otc - Purpose



Uses

Temporarily relieves minor pains associated with:

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

Warnings



Warnings

For external use only


Otc - When Using



When using this product

  • use as only directed
  • avoid contact with eyes and mucous membranes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens or symptoms persist more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children



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


Indications & Usage



Directions

  • ​open pouch and remove patch
  • carefully peel off protective packing and apply sticky side to affected area
  • adults and children 12 years of age and older:
  • do not wear patch for more than 8 hours
  • apply to affected area no more than 3 times daily
  • children under 12 years of age: consult a doctor

Inactive Ingredient



Inactive ingredients

aloe vera, aluminum hydroxide, BHT, castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydroxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminosilicate, methyl paraben, peg monostearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric dioxide, tocopherol acetate


Dosage & Administration



DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN KOREA


Package Label.Principal Display Panel



6159.1 - 6159.1

6159.1 - 6159.1


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