Hand and Wrist Pain 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 23:04:06

Label at a glance#

ProductHand and Wrist Pain 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, 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 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, 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 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

Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Purified Water), Ascorbic Acid (Vitamin C), Butylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Purica Granatum (Pomegranate) Extract, Saccharide Isomerate, Sodium Polyacrylate, Tochopheryl Acetate (Vitamin E), Trideceth-6, Vaccinium Angustifolium (Blueberry) Fruit Extract, Zemea (Corn) Propanediol

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-600-4642

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091387histamine dihydrochloride 0.025 % Topical CreamPSN1
1091387histamine dihydrochloride 0.25 MG/ML Topical CreamSCD1
1091387histamine dihydrochloride 0.025 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-8122-42024-01-30C16284748780-11030e365-5111-111a-e063-dadaa90a10e2Hand and Wrist Pain Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-8122-4Hand and Wrist Pain Cream119 g in 1 TUBECREAM1191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-8122HAND AND WRIST PAIN CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [SOMBRA COSMETICS, INC.]1Legacy NDC, 1 package rows20200327_49b35ba4-ecb0-4016-94b8-5351fbda8c26.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-812261577-8122-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

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
a83699af-6473-4a9a-a893-a3070783d2c749b35ba4-ecb0-4016-94b8-5351fbda8c262019-12-09WarningsExact identifier
spl id: a83699af-6473-4a9a-a893-a3070783d2c7
spl set id: 49b35ba4-ecb0-4016-94b8-5351fbda8c26

Reported adverse events (FAERS/openFDA)#

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