FDA.reportPublic FDA data

Pain Relieving Cream

Manufacturer
Mediapower, Inc. DBA Dr Newton's And Naturals
Effective date
2025-02-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:39

Label at a glance#

ProductPain Relieving Cream
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure10 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

• adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily • children under 12 years of age: do not use, consult a physician

Storage and handling

store between 68° and 77° F (20° and 25° C)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Histamine dihydrochloride 0.05% w/w

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Warnings

WARNINGS SECTION

For external use only

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

When using this product • avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water • do not bandage tightly or use a heating pad

Stop use and ask a doctor if • rash appears • condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days

If pregnant or breastfeeding, 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 Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily • children under 12 years of age: do not use, consult a physician

Other information

STORAGE AND HANDLING SECTION

store between 68° and 77° F (20° and 25° C)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Cetearyl alcohol, Emu oil, Glycerin, Ceteareth-20, Glucosamine sulfate, Dimethyl sulfone, Caprylic/capric triglyceride, Phenoxyethanol, Cetyl alcohol, Tocopherol acetate, Butylene glycol, Propylene glycol, Chamomile (Chamomilla recutita) flower extract, Rosemary (Rosemarinus officinalis) leaf extract, Indian frankincense (Boswellia serrata) extract, Ethylhexylglycerin.

Questions or comments?

OTC - QUESTIONS SECTION

+1-866-788-5951

You may also report serious side effects to this phone number.

Mon-Fri 8:00 A.M. - 6:00 P.M.

SPL UNCLASSIFIED SECTION

DR. NEWTON'S™ NATURALS

Temporary Pain Relief

Moisturizing Cream

Odorless, Greaseless, Stainless

Distributed by
Dr. Newton's Naturals
26 Thomas Drive,
Westbrook, ME 04092

To re-order call 800-280-5590

MADE IN USA

www.drnewtons.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PainRelieving1PainRelieving1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1542820histamine dihydrochloride 0.05 % Topical CreamPSN1
1542820histamine dihydrochloride 0.5 MG/ML Topical CreamSCD1
1542820histamine dihydrochloride 0.05 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85063-101-85Pain Relieving Cream85 g in 1 BOTTLE, PUMPCREAM851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85063-101PAIN RELIEVING CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [MEDIAPOWER, INC. DBA DR NEWTON'S AND NATURALS]1Current NDC, 1 package rows20250306_9eeea033-ae87-4d83-85d0-b8fa653a0806.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
85063-10185063-101-85

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
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EMU OIL344821WD61IACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETYL ALCOHOL936JST6JCNIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CHAMOMILEFGL3685T2XIACT
ROSEMARYIJ67X351P9IACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
Pain Relieving CreamHISTAMINE DIHYDROCHLORIDEMediapower, Inc. DBA Dr Newton's And Naturals9eeea033-ae87-4d83-85d0-b8fa653a08062025-02-19WarningsExact identifier
ndc (package): 85063-101-85
ndc (product): 85063-101
ndc11 (package): 85063010185
spl id: de7597a0-26c9-4a4b-b2b7-10ded0901117
spl set id: 9eeea033-ae87-4d83-85d0-b8fa653a0806

Reported adverse events (FAERS/openFDA)#

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