FDA Label for Meijer Extra Strength Cold And Hot Therapypain Relieving Topical Analgesic

View Indications, Usage & Precautions

Meijer Extra Strength Cold And Hot Therapypain Relieving Topical Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution, 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.

Other



Drug Facts

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544


Otc - Purpose



Active ingredientsPurpose
Menthol 10%Topical analgesic
Methyl Salicylate 30%Topical analgesic

Uses



temporarily relieves minor pain associated with:

  • muscle sprains
  • muscle strains
  • simple backache
  • bruises
  • arthritis

Warnings



For external use only

Test on a small patch before applying generously.


Allergy Alert



If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.


When Using This Product



  • use only as directed. Read and follow all directions and warnings on this label
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in seven days

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
  • irritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, 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 (1-800-222-1222) right away.


Directions



Adults and children over 12 years:

  • apply to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.
  • Children 12 years or younger: ask a doctor


Other Information



Keep tightly closed. Store at room temperature.


Inactive Ingredients



acrylates/C10-30 alkyl acrylate crosspolymer, carbomer, ceteareth-20, cetearyl alcohol, oleth-3 phosphate, phenoxyethanol, polysorbate 60, sodium hydroxide, stearic acid, water.


Questions Or Comments?



1-866-567-8600


Principal Display Panel - 35.4 G Tube Carton



Compare to
Icy Hot®Active
Ingredients*

meijer®

EXTRA STRENGTH
cold & hot therapy

Menthol 10% (Topical Anangesic)
Methyl Salicylate 30% (Topical Anangesic)

Pain Relieving Cream

Body & Backache | Bruises | Arthritis | Sore Muscles

NET WT 1.25 OZ (35.4 g)


* Please review the disclaimer below.