FDA.reportPublic FDA data

MUSCLESHOK Back Pain Gel

Manufacturer
Wagner Solutions, LLC
Effective date
2019-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:29:46

Label at a glance#

ProductMUSCLESHOK Back Pain
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure7 sections

Indications and uses

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

Dosage and administration

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: do not use; consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Histamine dihydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

when using this product

OTC - WHEN USING SECTION

  • do not bandage tightly
  • do not apply to wounds or damaged skin
  • avoid contact with eyes or mucous membranes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • sympotms 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: do not use; consult a doctor

Other information

SPL UNCLASSIFIED SECTION

store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica Montana Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Methylsulfonylmethane (MSM), Phenoxyethanol, Triethanolamine, Water (Aqua)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72378-01372378-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANAO80TY208ZWIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
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
0742fe89-8157-5b13-e063-6394a90afe21f364f6b5-8260-40ad-adf6-a8d44fbf58b12023-10-09WarningsExact identifier
spl set id: f364f6b5-8260-40ad-adf6-a8d44fbf58b1

Reported adverse events (FAERS/openFDA)#

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