FDA.reportPublic FDA data

Arthritis Pain Relief Cream

Manufacturer
Sombra Cosmetics, Inc.
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:06

Label at a glance#

ProductArthritis Pain Relief Cream
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis

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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Histamine Dihydrochloride 0.025%

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

PURPOSE

OTC - PURPOSE SECTION

PURPOSE

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with arthritis

Warnings

WARNINGS SECTION

For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in this 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 use and ask doctor if: rash appears.  Condition worsens. If symptoms persist for more than 7 days or if symptoms clear up and occur again within a few days.

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

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Purified Water), Butylene Glycol, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Methylsulfonylmethane (MSM), Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Chondroitin Sulfate, Glucosamine Sulfate

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-600-4642

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-8120-22025-01-30C16284748780-12cef2736-635f-d83d-e063-dadaa90ab31fArthritis Pain Relief Cream
61577-8120-32025-01-30C16284748780-12cef2736-635f-d83d-e063-dadaa90ab31fArthritis Pain Relief Cream
61577-8120-42025-01-30C16284748780-12cef2736-635f-d83d-e063-dadaa90ab31fArthritis Pain Relief Cream
61577-8120-92025-01-30C16284748780-12cef2736-635f-d83d-e063-dadaa90ab31fArthritis Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-8120-2Arthritis Pain Relief Cream59 g in 1 JARCREAM591
61577-8120-3Arthritis Pain Relief Cream59 g in 1 TUBECREAM591
61577-8120-4Arthritis Pain Relief Cream119 g in 1 JARCREAM1191
61577-8120-9Arthritis Pain Relief Cream266 g in 1 JARCREAM2661

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-8120ARTHRITIS PAIN RELIEF CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [SOMBRA COSMETICS, INC.]1Current NDC, Legacy NDC, 4 package rows20200414_3d3bdd7a-5ee3-487b-b589-a161c553e0ba.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-812061577-8120-4, 61577-8120-2, 61577-8120-3, 61577-8120-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
EMU OIL344821WD61IACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
SUNFLOWER OIL3W1JG795YIIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
EDETATE SODIUM TETRAHYDRATEL13NHD21X6IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TOCOPHEROLR0ZB2556P8IACT
TRIDECETH-63T5PCR2H0CIACT
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
ndc (package): 61577-8120-4
ndc (package): 61577-8120-2
ndc (package): 61577-8120-9
ndc (product): 61577-8120
ndc11 (package): 61577812004
ndc11 (package): 61577812009
ndc11 (package): 61577812002
f734d5e0-e435-4834-bf8e-4fa614d1fd4c3d3bdd7a-5ee3-487b-b589-a161c553e0ba2019-12-09WarningsExact identifier
spl id: f734d5e0-e435-4834-bf8e-4fa614d1fd4c
spl set id: 3d3bdd7a-5ee3-487b-b589-a161c553e0ba

Reported adverse events (FAERS/openFDA)#

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