Family Wellness Hot Cold Patch 1 ct ZDP

Manufacturer
Family Dollar Services, Inc.
Effective date
2022-03-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:49:01

Label at a glance#

ProductFamily Wellness Cold Hot
Active ingredientMENTHOL
Label structure14 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Menthol 5%..........................................................................Topical analgesic

OTC - PURPOSE SECTION

Uses

  • temporarily relieves minor aches and pains of muscles and joints associated with:
  • simple backache
  • arthritis
  • strains bruises
  • sprains

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • redness over the affected area

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with eyes or 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 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

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

  • open pouch and remove patch
  • carefully peel off protective backing 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

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

alcohol, aluminum glycinate, glycerin, kaolin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monoleate, tartaric acid, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Midwood Brands, LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

9021190211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN3
420222menthol 0.05 MG/MG Medicated PatchSCD3
420222menthol 5 % Medicated PatchSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-208-01Family Wellness Cold Hot1 in 1 POUCHPATCH13
55319-208-01Family Wellness Cold Hot1 in 1 PATCHPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-208FAMILY WELLNESS COLD HOT (MENTHOL) PATCH [FAMILY DOLLAR SERVICES, INC.]3Legacy NDC, 2 package rows20220402_96cb65e6-566a-47d0-e053-2995a90af9bc.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-20855319-208-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
db8b029c-c502-4df1-e053-2995a90ae72f96cb65e6-566a-47d0-e053-2995a90af9bc2022-03-31WarningsExact identifier
spl id: db8b029c-c502-4df1-e053-2995a90ae72f
spl set id: 96cb65e6-566a-47d0-e053-2995a90af9bc

Reported adverse events (FAERS/openFDA)#

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