Label: CAPSAICIN cream

  • NDC Code(s): 50488-1025-1, 50488-1025-2, 50488-1025-5
  • Packager: Alexso, 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 September 23, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    CAPSAICIN – Capsaicin 0.025% Cream

    Alexso, Inc.

    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.

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    Capsaicin 0.025% Cream


    Drug Facts

  • Active ingredient

    Capsaicin 0.025%

  • Purpose

    External analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints due to:

    • simple backache

    • arthritis

    • strains

    • sprains

  • Warnings

    For external use only

    Read all warnings and directions before use. Test first on small area of skin.

    Do not use

    • On wounds or damaged skin

    • If you are allergic to capsicum or chili peppers

    When using this product

    • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.

    • Avoid contact with the eyes, lips, nose and mucous membranes

    • Do not tightly wrap or bandage the treated area

    • Do not apply heat to the treated area immediately before or after use

    Stop use and ask a doctor if

    • Condition worsens or does not improve after regular use

    • Severe burning persists or blistering occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 18 years of age and older:

    Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily.

    Children under 18 years: Ask a doctor

  • Other information

    Store at room temperature 15°-30°C (59°-86°F)

  • Inactive ingredients

    Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine

    Capsaicin 0.025% cream

    NDC 50488-1025-1

    120 grams

    Capsaicin 0.025% cream

    NDC 50488-1025-5

    50 grams

    Capsaicin 0.025% cream

    NDC 50488-1025-2

    25 grams

    Alexso, Inc

  • PRINCIPAL DISPLAY PANEL

    NDC 50488-1025-1
    Capsaicin 0.025% Cream
    120 grams

    PRINCIPAL DISPLAY PANEL
NDC 50488-1025-1
Capsaicin 0.025% Cream
120 grams

  • PRINCIPAL DISPLAY PANEL

    NDC 50488-1025-5
    Capsaicin 0.025% Cream
    50 grams

    NDC 50488-1025-5
Capsaicin 0.025% Cream
50 grams

  • PRINCIPAL DISPLAY PANEL

    NDC 50488-1025-2
    Capsaicin 0.025% Cream
    25 grams

    NDC 50488-1025-2
Capsaicin 0.025% Cream
25 grams

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-1025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50488-1025-11 in 1 CARTON10/01/2018
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:50488-1025-51 in 1 CARTON10/01/2018
    250 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:50488-1025-21 in 1 CARTON10/01/2018
    325 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/01/2018
    Labeler - Alexso, Inc (963338061)