Label: ARTHRITIS PAIN RELIEF CREAM- histamine dihydrochloride cream
- NDC Code(s): 61577-8120-2, 61577-8120-3, 61577-8120-4, 61577-8120-9
- Packager: Sombra Cosmetics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 9, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Keep out of reach of children
- PURPOSE
- Uses
-
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
-
Inactive Ingredients
Aqua (Purified Water), Butylene Glycol, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Methylsulfonylmethane (MSM), Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Chondroitin Sulfate, Glucosamine Sulfate
- Questions or Comments?
- Label
-
INGREDIENTS AND APPEARANCE
ARTHRITIS PAIN RELIEF CREAM
histamine dihydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-8120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE .00025 g in 1 g Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EMU OIL (UNII: 344821WD61) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) SUNFLOWER OIL (UNII: 3W1JG795YI) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TOCOPHEROL (UNII: R0ZB2556P8) TRIDECETH-6 (UNII: 3T5PCR2H0C) CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-8120-4 119 g in 1 JAR; Type 0: Not a Combination Product 12/10/2019 2 NDC:61577-8120-2 59 g in 1 JAR; Type 0: Not a Combination Product 12/10/2019 3 NDC:61577-8120-3 59 g in 1 TUBE; Type 0: Not a Combination Product 12/10/2019 4 NDC:61577-8120-9 266 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(61577-8120) , label(61577-8120)
