GLUCOSAMINE CREAM EXTRA STRENGTH- histamine dihydrochloride cream 
IDEAZ, 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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Glucosamine Cream EXTRA STRENGTH

Drug Facts

Active Ingredient

Histamine Dihydrochloride 0.05%

Purpose

Topical Analgesic

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

Warnings For external use only

When using this product

Do not use 

Discontinue use and consult a physician if: Condition worsens or if symptoms persists 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

Directions

For use by adults and children over 12 years:

Apply to affected area not more than 3 to 4 times daily.

Inactive ingredients Deionized water, cetearyl alcohol, emu oil, glycerine, ceteareth-20, glucosamine sulfate, dimethyl sulfone, caprylic capric triglyceride, phenoxyethanol, cetyl alcohol, methyl paraben, tocopherol acetate, butylene glycol, propylene glycol, chamomilla recutita flower extract, rosmarinus officinalis leaf extract, boswellia serrata extract, propyl paraben

Pain Relief On Contact

Dual Action Moisturizing Cream

Odorless, Greaseless, Stainless.

Made in USA

For re-orders call 800-280-5590

www.drnewtons.com

Distributed by

Dr. Newton's Naturals

26 Thomas Drive

Westbrook, ME 04092

Packaging

image description

GLUCOSAMINE CREAM EXTRA STRENGTH 
histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78983-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EMU OIL (UNII: 344821WD61)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CHAMOMILE (UNII: FGL3685T2X)  
ROSEMARY (UNII: IJ67X351P9)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78983-101-8585 g in 1 TUBE; Type 0: Not a Combination Product09/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/08/2022
Labeler - IDEAZ, LLC (873184431)

Revised: 2/2023
Document Id: f4d51157-cb63-84d6-e053-2a95a90aadb0
Set id: f4d414b7-89e7-ad65-e053-2a95a90a25d4
Version: 3
Effective Time: 20230216
 
IDEAZ, LLC