Label: CAPZIX- 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 December 30, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient: Capsaicin 0.1%

  • PURPOSE

    Purpose: Topical Analgesic

  • INDICATIONS & USAGE

    Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes.
    Do not apply to wounds or damaged skin. Do not bandage tightly or apply local heat (such as heating pads) to the area of use. Stop use and ask  doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions – Adults and children over 18
    Apply to affected area not more than 3 to 4 times daily.
    If product comes in contact with hands, wash with soap and water.
    For children under 18 years of age ask a doctor.

  • STORAGE AND HANDLING

    Other Information: STORE TIGHTLY CLOSED, IN A COOL DRY PLACE

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cetyl Alcohol, Petrolatum, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Isopropyl Myristate, Benzyl Alcohol, Citric Acid.

  • SPL UNCLASSIFIED SECTION

    High Potency Pain Relief

    For Arthritis, Sore Muscles, Joint and Back Pain Relief

    NDC# 72847-316-20

    Distributed by: TopRail Medical Products   Glencoe, IL   www.toprailmedical.com   Made in the USA

  • Packaging

    label

  • INGREDIENTS AND APPEARANCE
    CAPZIX 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72847-316
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.001 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72847-316-201 in 1 CARTON07/19/2019
    156.6 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 finalpart34807/19/2019
    Labeler - Toprail Chp Llc. (080783804)
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