Meijer Extra Strength Cold And Hot Therapypain Relieving Cream
FDA Label NDC 41250-378

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution, Inc for the product Meijer Extra Strength Cold And Hot Therapypain Relieving (NDC 41250-378). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, allergy alert, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (35.4 g Tube Carton)

Principal Display Panel (35.4 g Tube Carton)

* Please review the disclaimer below.