ARTHRITIS PAIN RELIEF CREAM- histamine dihydrochloride cream 
Sombra Cosmetics Inc.

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Australian Dream Arthritis Cream

Active Ingredients

Histamine Dihydrochloride .025%

Purpose

External Analgesic

Keep out of reach of children

Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backaches, strains & 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 use and ask doctor if: rash appears. condition worsens, if symptoms persist 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.

Inactive Ingredients

Aqua (Purified Water), Butylene Glycol, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Helianthus
Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Methylsulfonylmethane (MSM),
Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate
(Vitamin E), Trideceth-6, Chondroitin Sulfate, Glucosamine Sulfate

Questions or Comments

Call 1-888-600-4642

Dosage and Administration

Apply no more than 3 to 4 times daily.

Warnings Section

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 use and ask doctor if: rash appears. condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Indications and Usage Section

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.

AD Arthritis 9oz Carton

AD Arthritis 9oz Carton

ARTHRITIS PAIN RELIEF CREAM 
histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-8120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.00025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HELIANTHUS ANNUUS (SUNFLOWER) SEED (UNII: R9N3379M4Z)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
TETRASODIUM EDTA (UNII: MP1J8420LU)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
EMU OIL (UNII: 344821WD61)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
WATER (UNII: 059QF0KO0R)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-8120-51 in 1 CARTON10/23/2024
1NDC:61577-8120-4119 g in 1 JAR; Type 0: Not a Combination Product
2NDC:61577-8120-81 in 1 CARTON10/23/2024
2NDC:61577-8120-9266 g in 1 JAR; Type 0: Not a Combination Product
3NDC:61577-8120-11 in 1 CARTON10/23/2024
3NDC:61577-8120-259 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/23/2024
Labeler - Sombra Cosmetics Inc. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
Sombra Cosmetics Inc.097464309manufacture(61577-8120) , label(61577-8120)

Revised: 5/2026
Document Id: 523333ee-ecce-bcf7-e063-6394a90aea60
Set id: 523333ee-eccd-bcf7-e063-6394a90aea60
Version: 1
Effective Time: 20260521
 
Sombra Cosmetics Inc.