BAKERS BEST ARTHRITIS PAIN RELIEF- histamine dihydrochloride cream 
Baker's Best Health Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Baker's Best Arthritis Pain Relief Cream

Drug Facts

Active Ingredient:

Histamine DHCl (0.03%)

Topical Analgesic

Indications:

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

Warnings:

For external use only. • Avoid contact with eyes. • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children. 

If swallowed, consult physician.

Do not apply

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. • Children under two-years of age: consult a physician.

Additional Information:

• Store at room temperature.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Ilex Paraguariensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Sodium Polyacrylate, Sorbitan Olivate, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

Label2

BAKERS BEST ARTHRITIS PAIN RELIEF 
histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76102-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA (UNII: O80TY208ZW)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CORN (UNII: 0N8672707O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76102-030-0256.7 g in 1 JAR; Type 0: Not a Combination Product07/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/08/2019
Labeler - Baker's Best Health Products, LLC (967388476)

Revised: 7/2019
Document Id: 8ca08af2-7edc-132f-e053-2a95a90a21df
Set id: 869735f9-335e-4a5e-adfc-91167ae943c5
Version: 1
Effective Time: 20190701
 
Baker's Best Health Products, LLC