Label: SURE RELIEF SR RELIEF- 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 March 10, 2016

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

  • Active Ingredient

    Active Ingredient

    Capsaicin 0.025%

  • Purpose

    Purpose

    Topical Analgesic

  • Uses

    Uses

    for the temporary relief of minor aches and painsof muscles and joints associated with a simple backache,

    athritis, strains and sprains

  • Warnings

    Warnings

    For external use only

    • This is not a face cream. Do not apply to the face.
    • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin
    • Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
    • Do not bandage tightly
    • Do not apply within 1 hour before or after bath, shower, hot tub, saunaor vigrous exercise
    • Warm water, perspiration or open pores can intensify the impact of this product and bruning sensation.
    • Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

    When using this product  Do not get into eyesand avoid contact with mucous membranes. If contact

    occurs or if pain, discomfort or skin redness occurs, continuously rinse with cool water and seek medical help.

    Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear

    up and occur again within a few days. Stop using and get immediate medical attention if experience burning,

    pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.

  • KEEP OUT OF REACH OF CHILDREN

    If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

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

    If inhaled, remove the fresh air. If breathing is difficult, get medical attention immediately.

  • Directions

    Directions

    • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
    • Before using on children under 18 years of age consult a physician.
    • Apply sparingly to affected area not more than 4 times daily. However, for the first use, apply to small area to test for sensitivity or skin reaction.
    • Gently massage into skin until fully absorbed.
    • Wash hands with soap and water thoroughly after each applicationto avoid spreading to the eyes or other sensitive mucous membranes.
  • STORAGE AND HANDLING

    WARNING: FLAMMABLE PRODUCT

    Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

  • Inactive Ingredients

    Inactive Ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice,

    Aqua (Deionized Water), Arnica Montana Extract, Bosswellia Serrata Extract,

    Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8,

    Phenoxyethanol, Polysorbate-20, Triethanolamine

  • QUESTIONS

    FOR QUESTIONS OR COMMENTS:

    info@pindintl.com

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SURE RELIEF SR RELIEF 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69837-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.025 mg  in .001 g
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TRIETHANOLAMINE GLUTAMATE (UNII: M71CZB7HUY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69837-210-101 in 1 CARTON
    1NDC:69837-210-09118 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 finalpart34803/10/2016
    Labeler - International Brand Management, LLC (079794940)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Brand Management, LLC079794940manufacture(69837-210)