FDA.reportPublic FDA data

ARTHRITIS PAIN RELIEF

Manufacturer
PainX LLC
Effective date
2022-11-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:26

Label at a glance#

ProductARTHRITIS PAIN RELIEF
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and bruises.

Dosage and administration

For use by Adults and children over 12 years. Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily. Children 12 years or younger consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HISTAMINE DIHYDROCHLORIDE 0.03%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and bruises.

WARNINGS

WARNINGS SECTION

For external use only.


Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.


When using this product avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.


Do not bandage tightly or use a heating pad.


Stop using and ask doctor if

  • Rash appears.
  • Condition worsens, if symptoms persists for more than 7 days, or if symptoms clear up and occur again within a few days.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • For use by Adults and children over 12 years.
  • Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.
  • Children 12 years or younger consult a physician.

PREGNANCY 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 CENTRE RIGHT AWAY.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Store between 40°F and 86°F (4°C and 30°C)
  • Tamper Evident Feature: do not use if seal under cap is torn, broken or missing.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Cetearyl Alcohol, Dimethicone, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Methylsulfonylmethane, Glyceryl Stearate, PEG-100 Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Emu Oil, Stearic
Acid, Tocopheryl (Vitamin E) Acetate, Glucosamine Hydrochloride, Phenoxyethanol, Menthol, Carbomer, Curcuma Longa (Turmeric) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Triethanolamine, Ethyhexylglycerin, Disodium EDTA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_PainX_11901b UC_PainX_119

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2167855histamine dihydrochloride 0.03 % Topical CreamPSN1
2167855histamine dihydrochloride 0.3 MG/ML Topical CreamSCD1
2167855histamine dihydrochloride 0.03 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83041-101-142024-01-30C16284748780-11030e365-0ea7-111a-e063-dadaa90a10e2PAINX - ARTHRITIS PAIN RELIEF (83041-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83041-101-14ARTHRITIS PAIN RELIEF119 g in 1 JARCREAM1191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83041-101ARTHRITIS PAIN RELIEF (HISTAMINE DIHYDROCHLORIDE) CREAM [PAINX LLC]1Legacy NDC, 1 package rows20221108_ece6bea2-19b5-b233-e053-2995a90ad832.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83041-10183041-101-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
JOJOBA OIL724GKU717MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STEARIC ACID4ELV7Z65APIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
DIMETHICONE92RU3N3Y1OIACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
MENTHOLL7T10EIP3AIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TURMERIC856YO1Z64FIACT
TROLAMINE9O3K93S3TKIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SAFFLOWER OIL65UEH262ISIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
DIMETHYL SULFONE9H4PO4Z4FTIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
EMU OIL344821WD61IACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

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
ece6bea2-19b6-b233-e053-2995a90ad832ece6bea2-19b5-b233-e053-2995a90ad8322022-11-07WarningsExact identifier
spl id: ece6bea2-19b6-b233-e053-2995a90ad832
spl set id: ece6bea2-19b5-b233-e053-2995a90ad832

Reported adverse events (FAERS/openFDA)#

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