Label: RECOVERY- stearic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 29, 2018

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  • ACTIVE INGREDIENT

    Stearic Acid

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, etc

  • PURPOSE

    Warm up pre/after-execise and after shower

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • WARNINGS

    • Avoid to touch your face and eye. (Avoid to let the cream to make contacts with your face and eyes.) If the situcation happens, flush the part with water for 15 minutes.
    • Do not apply to wounds or damaged skin.
    • When a pain caused by the cream continues for more than 10 days, or a redness/irritation happens, or any situation happens to children under 12-year-old, please consult a physician immediately.
  • DOSAGE & ADMINISTRATION

    for external use only


  • INDICATIONS & USAGE

    • Use Pre- Activity: Put on the FlexPower recovery cream and massage your body parts for 10 minutes to warm up before doing exercises. No matter what purpose of the workout is, applyting FlexPower can help to warm-up your body and deliver a better time of exercising.
    • Use After-Activty: After Applied- Use the FlexPower recovery cream as a lotion and massage when applying for warm-sensation after shower. Wash your hand with soap after application.
  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    RECOVERY 
    stearic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70042-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STEARIC ACID (UNII: 4ELV7Z65AP) (STEARIC ACID - UNII:4ELV7Z65AP) STEARIC ACID1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70042-0002-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/19/2018
    2NDC:70042-0002-2250 mL in 1 TUBE; Type 0: Not a Combination Product04/19/2018
    3NDC:70042-0002-3100 mL in 1 TUBE; Type 0: Not a Combination Product04/19/2018
    4NDC:70042-0002-460 mL in 1 TUBE; Type 0: Not a Combination Product04/19/2018
    5NDC:70042-0002-530 mL in 1 TUBE; Type 0: Not a Combination Product04/19/2018
    6NDC:70042-0002-62 mL in 1 JAR; Type 0: Not a Combination Product04/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/19/2018
    Labeler - Powerful X (689515038)
    Registrant - Powerful X (689515038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Powerful X689515038manufacture(70042-0002) , label(70042-0002) , pack(70042-0002)