ARTHRITIS PAIN RELIEF- histamine dihydrochloride cream

ARTHRITIS PAIN RELIEF by

Drug Labeling and Warnings

ARTHRITIS PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by PainX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Rash appears.
• Condition worsens, if symptoms persists for more than 7 days, or if symptoms clear up and occur again within a few days.

DIRECTIONS

• For use by Adults and children over 12 years.
• Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.
• Children 12 years or younger consult a physician.

PREGNANCY

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

KEEP OUT OF REACH OF CHILDREN

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

OTHER INFORMATION

• Store between 40°F and 86°F (4°C and 30°C)
• Tamper Evident Feature: do not use if seal under cap is torn, broken or missing.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARTHRITIS PAIN RELIEF 
histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83041-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.03 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83041-101-14	119 g in 1 JAR; Type 0: Not a Combination Product	11/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/07/2022

Labeler - PainX LLC (118688116)

Registrant - PainX LLC (118688116)