BACK PAIN CREAM- histamine dihydrochloride cream

Australian Dream Back Pain by

Drug Labeling and Warnings

Australian Dream Back Pain by is a Otc medication manufactured, distributed, or labeled by Sombra Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BACK PAIN CREAM 
histamine dihydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-8121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	.0005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Water (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-8121-4	119 g in 1 JAR; Type 0: Not a Combination Product	12/10/2019
2	NDC: 61577-8121-2	59 g in 1 JAR; Type 0: Not a Combination Product	12/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/09/2019

Labeler - Sombra Cosmetics, Inc. (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
Sombra Cosmetics, Inc.		097464309	manufacture(61577-8121) , label(61577-8121)