Label: BRONSON SOOTHE PAIN RELIEF- capsaicin cream

  • NDC Code(s): 83158-387-02, 83158-387-04
  • Packager: BRONSON NUTRITIONALS, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Capsaicin 0.025%

    PURPOSE

    External Analgesic

  • USES:

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

  • WARNINGS

    • For external use only. 
    • Avoid contact with eyes.
    • Do not apply to open wounds or damaged skin.
    • If symtoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    • If swallowed, contact physician.
    • Do not bandage tightly .
    • If pregnant or breast feeding, contact physician prior to use.
  • DIRECTIONS:

    Apply directly to affected area. Do not use more than four times per day.

  • INACTIVE INGREDIENTS:

    Aloe barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica montana Flower Extract, Ascorbyl Palmitate (Vitamin C), C13-14 Isoparaffin, Cetyl Alcohol, Chamomilla recutita (Chamomile) Extract, Diazolidinyl Urea, Emu Oil, Hamamelis virginiana (Witch Hazel) Distillate, Isopropyl Alcohol, Isopropyl Myristate, Lamium album (White Nettle) Extract, Laureth-7, Menthol, Methyl Paraben, Methylsulfonylmethane (MSM), Parfum (Fragrance), PEG-8, Polyacrylamide, Propyl Paraben, Propylene Glycol, Sorbitol, Tocopheryl Acetate (Vitamin E).

  • OTHER INFORMATION:

    • Store at room temperature.
    • Protect from light.
  • Package Labeling:59ml

    Label59ml

  • Package Labeling:118ml

    Label118ml

  • INGREDIENTS AND APPEARANCE
    BRONSON SOOTHE PAIN RELIEF 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83158-387
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EMU OIL (UNII: 344821WD61)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAMIUM ALBUM WHOLE (UNII: 046Y1357I6)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83158-387-0259 mL in 1 TUBE; Type 0: Not a Combination Product12/26/2022
    2NDC:83158-387-04118 mL in 1 TUBE; Type 0: Not a Combination Product12/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/26/2022
    Labeler - BRONSON NUTRITIONALS, LLC (130393494)
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