MUSCLESHOK BACK PAIN- histamine dihydrochloride gel

MUSCLESHOK Back Pain by

Drug Labeling and Warnings

MUSCLESHOK Back Pain by is a Otc medication manufactured, distributed, or labeled by Wagner Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

MUSCLESHOK BACK PAIN 
histamine dihydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72378-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72378-013-01	118 mL in 1 TUBE; Type 0: Not a Combination Product	02/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/20/2019

Labeler - Wagner Solutions, LLC (098004226)