Label: HAND AND WRIST PAIN CREAM- histamine dihydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61577-8122-4 - 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.
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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), Butylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Purica Granatum (Pomegranate) Extract, Saccharide Isomerate, Sodium Polyacrylate, Tochopheryl Acetate (Vitamin E), Trideceth-6, Vaccinium Angustifolium (Blueberry) Fruit Extract, Zemea (Corn) Propanediol
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- Label
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INGREDIENTS AND APPEARANCE
HAND AND WRIST PAIN CREAM
histamine dihydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-8122 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) Water (UNII: 059QF0KO0R) ASCORBIC ACID (UNII: PQ6CK8PD0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) 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) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PUNICA GRANATUM SEED (UNII: 7294Z34NS7) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TOCOPHEROL (UNII: R0ZB2556P8) TRIDECETH-6 (UNII: 3T5PCR2H0C) VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61577-8122-4 119 g in 1 TUBE; 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(61577-8122) , label(61577-8122)
