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  5. Label Information: Topcare Maximum Strength Pain Relieving Analgesic

FDA Label for Topcare Maximum Strength Pain Relieving Analgesic

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - WHEN USING
    7. OTC - DO NOT USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 74 ML BOTTLE LABEL

Topcare Maximum Strength Pain Relieving Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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.

Other



Drug Facts

Flammable

  • ♦keep away from fire or flame

    • DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007


Active Ingredients



Menthol 16%


Purpose



Topical analgesic


Uses



for the temporary relief of minor aches and pains of muscles and joints associated with:

  • ♦simple backache
  • ♦arthritis
  • ♦strains
  • ♦bruises
  • ♦sprains

Warnings



For external use only. Test on a small patch of skin before applying generously.


Otc - When Using



When using this product

  • ♦use only as directed
  • ♦avoid contact with the eyes and mucous membranes
  • ♦do not apply to wounds or damaged skin
  • ♦do not bandage tightly
  • ♦do not use with heating pads or other heating devices
  • ♦if redness is present, discontinue use and consult a doctor
  • ♦if skin irritation occurs, discontinue use
  • ♦a transient burning sensation may occur upon application but generally disappears in several days

Otc - Do Not Use



Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days


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 (1-800222-1222) immediately.


Directions



adults and children 12 years of age and older:

  • ♦apply generously to affected area
  • ♦massage into painful area until thoroughly absorbed into skin
  • ♦repeat if necessary, but not more than 3 to 4 times daily
  • ♦IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

    • Children 12 years or younger: ask a doctor


Other Information



store at room temperature


Inactive Ingredients



acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.


Questions Or Comments?



1-888-423-0139


Principal Display Panel - 74 Ml Bottle Label



TopCare
health®

COMPARE TO ICY HOT® ACTIVE INGREDIENT*

MAXIMUM STRENGTH
Cool n'
Heat
Roll-On Liquid
External Analgesic
with Menthol 16%

STAIN FREE

* Please review the disclaimer below.