MUSCLESHOK BACK PAIN- histamine dihydrochloride gel 
Wagner Solutions, LLC

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MUSCLESHOK Back Pain Gel

Drug Facts

Active ingredient

Histamine dihydrochloride 0.05%

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only

when using this product

  • 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

  • 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

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

Directions

  • 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

store at room temperature

Inactive Ingredients

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

Package Labeling:

Label

MUSCLESHOK BACK PAIN 
histamine dihydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72378-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA (UNII: O80TY208ZW)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72378-013-01118 mL in 1 TUBE; Type 0: Not a Combination Product02/20/201906/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/20/201906/30/2021
Labeler - Wagner Solutions, LLC (098004226)

Revised: 10/2023
Document Id: 0742fe89-8157-5b13-e063-6394a90afe21
Set id: f364f6b5-8260-40ad-adf6-a8d44fbf58b1
Version: 2
Effective Time: 20231009
 
Wagner Solutions, LLC