FDA.reportPublic FDA data

FAMILY CARE BACK PAIN THERAPY

Manufacturer
UNITED EXCHANGE CORP
Effective date
2011-12-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:28

Label at a glance#

ProductFAMILY CARE BACK PAIN THERAPY
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, CAPSICUM OLEORESIN
Label structure12 sections

Storage and handling

Other Information This product may cause allergic reaction in some individuals. Store in cool dry place away from direct sunlight.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
Camphor 80mg / patchTopical Analgesic
Menthol 24mg / patchTopical Analgesic
Capsicum Extract 16mg / patchTopical Analgesic

OTC - PURPOSE SECTION

Uses

For temporary relief of pains.

WARNINGS SECTION

Warnings

FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

When using this product
  • Use only as directed
  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • Do not use 1 hour prior to bathing or 30 minutes after bathing

OTC - STOP USE SECTION

Stop use and ask a doctor if
  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

INDICATIONS & USAGE SECTION

Directions
  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years, consult doctor before use
  • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches

STORAGE AND HANDLING SECTION

Other Information

This product may cause allergic reaction in some individuals. Store in cool dry place away from direct sunlight.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Aluminium glycinate, eucalyptus oil, glycerin, kaolin, mentha oil, polysorbate 80, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, polyacrylic acid solution, sorbitol solution, hydrotalcite, water

DOSAGE & ADMINISTRATION SECTION

Distributed By:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703


MADE IN KOREA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelimage of carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
853132camphor 80 MG / capsicum 16 MG / menthol 24 MG Medicated PatchPSN1
853132camphor 80 MG / Capsicum extract 16 MG / menthol 24 MG Medicated PatchSCD1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65923-901-372020-01-31C16284748780-19d75b9cf-e7b6-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-901-37FAMILY CARE BACK PAIN THERAPY1 in 1 BOXPATCH11
65923-901-37FAMILY CARE BACK PAIN THERAPY2 in 1 PACKETPATCH21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-901FAMILY CARE BACK PAIN THERAPY (CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM OLEORESIN ) PATCH [UNITED EXCHANGE CORP]1Legacy NDC, 2 package rows20111229_e3f69b3d-9376-41d6-bc63-a0f5ffc4ad91.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
CAPSICUM OLEORESINACTIVE INGREDIENTUW86K581WY1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
CAPSICUM OLEORESINACTIVE MOIETYUW86K581WY1
MENTHOLACTIVE MOIETYL7T10EIP3A1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-90165923-901-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
CAPSICUM OLEORESINUW86K581WYACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
EDETATE DISODIUM7FLD91C86KIACT
EUCALYPTUS OIL2R04ONI662IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
KAOLIN24H4NWX5COIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYVINYL ALCOHOL532B59J990IACT
WATER059QF0KO0RIACT

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
44ebfbf1-aa96-491c-b3ef-19018d6856a4e3f69b3d-9376-41d6-bc63-a0f5ffc4ad912011-12-27WarningsExact identifier
spl id: 44ebfbf1-aa96-491c-b3ef-19018d6856a4
spl set id: e3f69b3d-9376-41d6-bc63-a0f5ffc4ad91

Reported adverse events (FAERS/openFDA)#

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