Label: AUSTRALIAN DREAM BACK PAIN- histamine dihydrochloride cream
- NDC Code(s): 61577-8121-9
- Packager: Sombra Cosmetics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 18, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Keep out of reach of children
- PURPOSE
- 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
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- Label
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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 .0005 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-8121-9 266 g in 1 JAR; Type 0: Not a Combination Product 01/18/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M 01/18/2024 Labeler - Sombra Cosmetics, Inc. (097464309) Establishment Name Address ID/FEI Business Operations Sombra Cosmetics, Inc. 097464309 manufacture(61577-8121) , label(61577-8121)
