ZENOL POWERFULX RECOVERYCREAM (STEARIC ACID) CREAM [POWERFUL X]

ZENOL POWERFULX RECOVERYCREAM (STEARIC ACID) CREAM [POWERFUL X]
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NDC 70042-0001-1, 70042-0001-2, 70042-0001-3, 70042-0001-4, 70042-0001-5
Set ID 643580b9-a696-5afc-e053-2991aa0a367e
Category HUMAN OTC DRUG LABEL
Packager Powerful X
Generic Name
Product Class
Product Number
Application Number
  • 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

    1. Do not use in the following cases(Eczema and scalp wounds)
    2.Side Effects
    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
    3.General Precautions
    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    2)This product is for exeternal use only. Do not use for internal use
    4.Storage and handling precautions
    1)If possible, avoid direct sunlight and store in cool and area of low humidity
    2)In order to maintain the quality of the product and avoid misuse
    3)Avoid placing the product near fire and store out in reach of children

  • DOSAGE & ADMINISTRATION

    for external use only


  • INDICATIONS & USAGE

    Put on the cream and massage your body parts for 10 minutes to warm up before doing exercise.

    Apply cream and massge when applying for warm-sensation after shower.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ZENOL POWERFULX RECOVERYCREAM 
    stearic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70042-0001
    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:70042-0001-130 mL in 1 TUBE; Type 0: Not a Combination Product02/02/2018
    2NDC:70042-0001-260 mL in 1 TUBE; Type 0: Not a Combination Product02/02/2018
    3NDC:70042-0001-3100 mL in 1 TUBE; Type 0: Not a Combination Product02/02/2018
    4NDC:70042-0001-4250 mL in 1 TUBE; Type 0: Not a Combination Product02/02/2018
    5NDC:70042-0001-5500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/02/2018
    Labeler - Powerful X (689515038)
    Registrant - Powerful X (689515038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Powerful X689515038manufacture(70042-0001) , label(70042-0001) , pack(70042-0001)

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