AUSTRALIAN DREAM BACK PAIN- histamine dihydrochloride cream 
Sombra Cosmetics, Inc.

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Australian Dream Back Pain Cream

Active Ingredients

Histamine Dihydrochloride 0.05%

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

PURPOSE

PURPOSE

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with simple backache

Warnings

For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in this 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.

If pregnant or breast feeding, ask a health professional before use.

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

Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Purified Water), Ascorbic Acid (Vitamin C), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Chamomilla Recutita (Chamomile) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Ganoderma Lucidum (Reishi Mushroom) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Turmeric Extract, Zingiber Officinalis (Ginger) Extract

Questions or Comments?

Call 1-888-600-4642

Label

back pain 9oz label

AUSTRALIAN DREAM BACK PAIN 
histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-8121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE.0005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
EMU OIL (UNII: 344821WD61)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
LAURETH-7 (UNII: Z95S6G8201)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TURMERIC (UNII: 856YO1Z64F)  
GINGER (UNII: C5529G5JPQ)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
GANODERMA LUCIDUM WHOLE (UNII: J5P04QW0CF)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
BROMELAINS (UNII: U182GP2CF3)  
NIACIN (UNII: 2679MF687A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-8121-9266 g in 1 JAR; Type 0: Not a Combination Product01/18/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01/18/2024
Labeler - Sombra Cosmetics, Inc. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
Sombra Cosmetics, Inc.097464309manufacture(61577-8121) , label(61577-8121)

Revised: 1/2024
Document Id: b338df71-9ea9-40ae-8818-3c462c649540
Set id: 6555087a-368a-416c-a91e-d3612cb47968
Version: 8
Effective Time: 20240118
 
Sombra Cosmetics, Inc.