Meijer Cold & Hot Therapy Pain Relieving Cream 1.25oz 25349 ZDP

Manufacturer
Meijer, Inc.
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:27

Label at a glance#

ProductMeijer Cold and Hot Therapy
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Menthol 10%.................................................Topical Analgesic

Methyl Salicylate 30%...................................Topical Analgesic

OTC - PURPOSE SECTION

Uses

temporarily relieves minor pain associated with:

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

WARNINGS SECTION

Warnings

For external use only

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

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad

OTC - WHEN USING SECTION

When using this product

  • ​avoid contact with eyes or mucous membranes
  • do not bandage tightly

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs
  • redness of the skin is present

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

Directions

use only as directed

adults and children 12 years of age and older:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but not more than 4 times daily

childen under 12 years of age: ask a doctor

DOSAGE & ADMINISTRATION SECTION

Other Information

  • store at room temperature 20-25ºC (68-77ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients carbomer, cetostearyl alcohol, cetyl esters wax, polysorbate 60, purified water, steareth-20, stearic acid, trolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12341234

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSN3
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD3
311500menthol 10 % / methyl salicylate 30 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-858-35Meijer Cold and Hot Therapy35 g in 1 TUBECREAM353
41250-858-35Meijer Cold and Hot Therapy1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-858MEIJER COLD AND HOT THERAPY (MENTHOL, METHYL SALICYLATE) CREAM [MEIJER, INC.]3Legacy NDC, 2 package rows20221217_a97a10a7-1ad3-7ef4-e053-2a95a90a923e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-85841250-858-35

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
efe78e44-bc2a-4006-e053-2a95a90a45faa97a10a7-1ad3-7ef4-e053-2a95a90a923e2022-12-15WarningsExact identifier
spl id: efe78e44-bc2a-4006-e053-2a95a90a45fa
spl set id: a97a10a7-1ad3-7ef4-e053-2a95a90a923e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.