FDA.reportPublic FDA data

ROPANA Pain Relief Cream

Manufacturer
FUSION PAIN SOLUTIONS LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:09

Label at a glance#

ProductROPANA Pain Relief Cream
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure7 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Chldren under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Histamine DHCl 0.04%

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 simple backache, arthritis, strains, bruises, and sprains.

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Rash or irritation develops and lasts.
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. 

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Chldren under 2 years of age: consult a doctor.

Other Information:

SPL UNCLASSIFIED SECTION

Protct the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cinnamomum Cassia Oil, Curcuma Longa (Turmeric) Extract, Cyclopentasiloxane, Dodecane, Ethylhexylglycerin, Ethyl Vanillin, Glyceryl Stearate, Glycyrrhiza Glaba (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Stearic Acid, Triethanolamine, Xanthan Gum.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2645121histamine dihydrochloride 0.04 % Topical CreamPSN2
2645121histamine dihydrochloride 0.4 MG/ML Topical CreamSCD2
2645121histamine dihydrochloride 0.04 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83613-411-00ROPANA Pain Relief Cream118 mL in 1 JARCREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83613-411ROPANA PAIN RELIEF CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [FUSION PAIN SOLUTIONS LLC]2Current NDC, 1 package rows20231106_e0342aa3-ca80-40b7-bec6-1b33c4db398b.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83613-41183613-411-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
SHEA BUTTERK49155WL9YIACT
CETYL ALCOHOL936JST6JCNIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DODECANE11A386X1QHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CHINESE CINNAMON OILA4WO0626T5IACT
TURMERIC856YO1Z64FIACT
ETHYL VANILLINYC9ST449YJIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
XANTHAN GUMTTV12P4NEEIACT
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB

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
ROPANA Pain Relief CreamHISTAMINE DIHYDROCHLORIDEFUSION PAIN SOLUTIONS LLCe0342aa3-ca80-40b7-bec6-1b33c4db398b2023-11-06WarningsExact identifier
ndc (package): 83613-411-00
ndc (product): 83613-411
ndc11 (package): 83613041100
spl id: 09765451-b4c7-6a8d-e063-6294a90aa698
spl set id: e0342aa3-ca80-40b7-bec6-1b33c4db398b

Reported adverse events (FAERS/openFDA)#

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