Label: PICK ME PAD AZULENE MOISTURE- glycerin liquid

  • 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 September 4, 2017

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

  • ACTIVE INGREDIENT

    Glycerin

  • INACTIVE INGREDIENT

    Water, Butylene Glycol

  • PURPOSE

    Skin protectant

    Azulene moisture

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    After cleansing, gently wipe the entire face with the soft side of the pattern, and gently wipe in the direction of skin texture.

    You can also patch it like a facial pack in the dry areas. Close the cap tightly to prevent the pad from drying.

  • 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


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PICK ME PAD AZULENE MOISTURE 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71638-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.145 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71638-0006-1110 g in 1 BOTTLE; Type 0: Not a Combination Product09/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34709/04/2017
    Labeler - Dermafirm INC. (690171603)
    Registrant - Dermafirm INC. (690171603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermafirm INC.690171603label(71638-0006) , pack(71638-0006) , manufacture(71638-0006)