ARTHRITIS PAIN RELIEF- histamine dihydrochloride cream 
PainX 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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PAINX - ARTHRITIS PAIN RELIEF (83041-101)

ACTIVE INGREDIENT

HISTAMINE DIHYDROCHLORIDE 0.03%

PURPOSE

TOPICAL ANALGESIC

USES

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

WARNINGS

For external use only.


Do not use on wounds or damaged skin or if you are allergic to ingredients in the product.


When using this product avoid contact with eyes. If product gets into eyes, rinse thoroughly with water.


Do not bandage tightly or use a heating pad.


Stop using and ask doctor if

DIRECTIONS

IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTRE RIGHT AWAY.

OTHER INFORMATION

INACTIVE INGREDIENTS

Water, Cetearyl Alcohol, Dimethicone, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Methylsulfonylmethane, Glyceryl Stearate, PEG-100 Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Emu Oil, Stearic
Acid, Tocopheryl (Vitamin E) Acetate, Glucosamine Hydrochloride, Phenoxyethanol, Menthol, Carbomer, Curcuma Longa (Turmeric) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Triethanolamine, Ethyhexylglycerin, Disodium EDTA.

01b UC_PainX_119

ARTHRITIS PAIN RELIEF 
histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83041-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.03 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
JOJOBA OIL (UNII: 724GKU717M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
MENTHOL (UNII: L7T10EIP3A)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TURMERIC (UNII: 856YO1Z64F)  
TROLAMINE (UNII: 9O3K93S3TK)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
EMU OIL (UNII: 344821WD61)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83041-101-14119 g in 1 JAR; Type 0: Not a Combination Product11/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/07/2022
Labeler - PainX LLC (118688116)
Registrant - PainX LLC (118688116)

Revised: 11/2022
Document Id: ece6bea2-19b6-b233-e053-2995a90ad832
Set id: ece6bea2-19b5-b233-e053-2995a90ad832
Version: 1
Effective Time: 20221107
 
PainX LLC