FDA.reportPublic FDA data

PainZone Light Cream

Manufacturer
MEDZONE PRODUCTS LLC | Dhaliwal Laboratories LLC
Effective date
2020-12-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:35:54

Label at a glance#

ProductPainZone Light
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

Uses: For temporary relief of minor aches and pains. Used for muscle and joint pain associated with arthritis, backache, strains, sprains

Dosage and administration

Directions Use only as directed Adults and children 12 years of age and older, rub a thin layer to affected area 3-4 times daily Children under 12 years of age consult a physician Wash hands after applying

Storage and handling

Store at 68-86 degrees with lid tightly closed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientUse
Menthol 3.5%Topical Analgesic

Uses

OTC - PURPOSE SECTION

Uses:

  • For temporary relief of minor aches and pains. Used for muscle and joint pain associated with arthritis, backache, strains, sprains

Do Not Use

OTC - DO NOT USE SECTION

Do not use:

  • On wounds or damaged skin
  • With a heating pad
  • On children under 12 years of age
  • If pregnant or breast feeding

Stop use and ask a physicinan if:

OTC - ASK DOCTOR SECTION

Stop use and ask a physician if:

  • Conditiion worsens or symtops persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation occurs

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
Use only as directed
Adults and children 12 years of age and older, rub a thin layer to affected area 3-4 times daily
Children under 12 years of age consult a physician
Wash hands after applying

Storage

STORAGE AND HANDLING SECTION

Store at 68-86 degrees with lid tightly closed

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Alcohol Denaturated, Camphor, Carbomer, Ethylhexylglycerin, Glycerin, Jaanese Green tea ( Camellia Sinesis) Extract, Laureth-4, Petrolatum, Pineapple (Ananas Sativus) Extract, Polysorbate 80, Propylene Glycol, Phenoxyethanol, Triethanolamine, Water

Warnings For External Use Only:

WARNINGS SECTION


Warnings For External Use Only:

  • Avoid contact with eyes and mucous membranes. Do not bandage tightly

Distributed By

SPL UNCLASSIFIED SECTION

Distributed by: MedZone

Lenexa, Kansas

Ph 913-948-9663

www.medzonecorp.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Zone 1Pain Zone 1Pain Zone 2Pain Zone 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2000534menthol 3.5 % Topical CreamPSN6
2000534menthol 35 MG/ML Topical CreamSCD6
2000534menthol 3.5 % Topical CreamSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70338-651-012022-01-28C16284748780-1d6a99b39-b5cf-a426-e053-dadaa90af4c2PainZone Light Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70338-651-01PainZone Light113 g in 1 TUBECREAM1136

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70338-651PAINZONE LIGHT CREAM [MEDZONE PRODUCTS LLC]6Legacy NDC, 1 package rows20201227_85689a6e-1265-22a9-e053-2a91aa0aecfd.zip

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
70338-65170338-651-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MENTHOLL7T10EIP3AACTIB
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
LAURETH-46HQ855798JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIETHANOLAMINE DODECYLBENZENESULFONATE8HM7ZD48HNIACT
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE)9Q5W5G6461IACT
ALCOHOL3K9958V90MIACT
PINEAPPLE2A88ZO081OIACT
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT

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
b76af55b-53a2-19e5-e053-2995a90af56285689a6e-1265-22a9-e053-2a91aa0aecfd2020-12-26WarningsExact identifier
spl id: b76af55b-53a2-19e5-e053-2995a90af562
spl set id: 85689a6e-1265-22a9-e053-2a91aa0aecfd

Reported adverse events (FAERS/openFDA)#

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