AUSTRALIAN DREAM BACK PAIN- histamine dihydrochloride cream

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

Histamine Dihydrochloride .025%

Purpose

Topical Analgesic

Keep out of reach of children

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

Uses

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

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.

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

Dosage and Administration

Apply a thin layer to pain site and massage until thoroughly absorbed into skin. 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 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.

Indications & Usage Section

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

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.

AD 2 oz Back Pain Cream Box

INGREDIENTS AND APPEARANCE

AUSTRALIAN DREAM BACK PAIN 
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	0.0005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GANODERMA LUCIDUM WHOLE (UNII: J5P04QW0CF)
TETRASODIUM EDTA (UNII: MP1J8420LU)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
GINGER (UNII: C5529G5JPQ)
EMU OIL (UNII: 344821WD61)
LAURETH-7 (UNII: Z95S6G8201)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HELIANTHUS ANNUUS (SUNFLOWER) SEED (UNII: R9N3379M4Z)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
BROMELAINS (UNII: U182GP2CF3)
NIACIN (UNII: 2679MF687A)
TURMERIC (UNII: 856YO1Z64F)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
MAGNESIUM SULFATE (UNII: DE08037SAB)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-8121-3	1 in 1 CARTON	09/29/2023
1	NDC: 61577-8121-2	59 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 61577-8121-5	1 in 1 CARTON	02/20/2026
2	NDC: 61577-8121-4	119 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 61577-8121-8	1 in 1 CARTON	01/18/2024
3	NDC: 61577-8121-9	266 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/29/2023

Labeler - Sombra Cosmetics Inc. (097464309)

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