Label: CAPSAICIN cream

  • NDC Code(s): 69420-6025-1, 69420-6025-5
  • Packager: SA3, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2024

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  • SPL UNCLASSIFIED SECTION

    CAPSAICIN – Capsaicin 0.025% Cream

    SA3, 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

    Topical 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

    • Apply to wounds or damaged skin

    • Bandage tightly

    • 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 if symptoms persist for more than 7 days or clear up and occur again within a few days

    • Severe burning persists or blistering occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately. If pregnant or breast-feeding, ask a health professional before use.

  • Directions

    Adults and children 2 years of age and older:

    Apply to affected area not more than 3 to 4 times daily. Wash hands thoroughly with soap and water immediately after application.

    Children under 2 years: consult a doctor

  • Other information

    Store at room temperature 15°-30°C (59°-86°F). Protect the product from excessive heat and direct sun.

  • 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 69420-6025-5

    50 grams

    SA3, LLC

    PRINCIPAL DISPLAY PANEL Capsaicin 0.025% cream NDC 69420-6025-5 50 grams SA3, LLC

  • PRINCIPAL DISPLAY PANEL

    Capsaicin 0.025% cream

    NDC 69420-6025-1

    120 grams

    SA3, LLC

    PRINCIPAL DISPLAY PANEL Capsaicin 0.025% cream NDC 69420-6025-1 120 grams SA3, LLC

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69420-6025
    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)  
    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:69420-6025-550 g in 1 TUBE; Type 0: Not a Combination Product06/11/2021
    2NDC:69420-6025-1120 g in 1 TUBE; Type 0: Not a Combination Product06/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/11/2021
    Labeler - SA3, LLC (079627454)
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