Label: CAPSAICIN cream

  • 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 October 23, 2019

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  • SPL UNCLASSIFIED SECTION

    CAPSAICIN – Capsaicin 0.025% Cream

    7T Pharma, LLC

    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

  • PRINCIPAL DISPLAY PANEL

    Capsaicin 0.025% cream

    NDC 70645-025-25

    25 grams

    PRINCIPAL DISPLAY PANEL Capsaicin 0.025% cream NDC 70645-025-25 25 grams

  • PRINCIPAL DISPLAY PANEL

    Capsaicin 0.025% cream

    NDC 70645-025-50

    50 grams

    PRINCIPAL DISPLAY PANEL Capsaicin 0.025% cream NDC 70645-025-50 50 grams

  • PRINCIPAL DISPLAY PANEL

    Capsaicin 0.025% cream

    NDC 70645-025-12

    120 grams

    PRINCIPAL DISPLAY PANEL Capsaicin 0.025% cream NDC 70645-025-12 120 grams

    7T Pharma, LLC

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70645-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN25 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70645-025-12120 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2019
    2NDC:70645-025-2525 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2019
    3NDC:70645-025-5050 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/01/2019
    Labeler - 7T Pharma LLC (080220022)
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