Label: AUSTRALIAN DREAM BACK PAIN- histamine dihydrochloride cream
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NDC Code(s):
61577-8121-2,
61577-8121-3,
61577-8121-4,
61577-8121-5, view more61577-8121-8, 61577-8121-9
- Packager: Sombra Cosmetics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 21, 2026
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
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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
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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
- Dosage and Administration
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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
- AD 2 oz Back Pain Cream Box
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INGREDIENTS AND APPEARANCE
AUSTRALIAN DREAM BACK PAIN
histamine dihydrochloride creamProduct 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)
