Label: HARUTO BEAUTY MICRONEEDLE ACNE PIMPLEPATCH- sodium hyaluronate patch

  • 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 May 17, 2020

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  • ACTIVE INGREDIENT

    SODIUM HYALURONATE

  • INACTIVE INGREDIENT

    Trehalose
    Propanediol
    Calendula Officinalis Flower Extract
    Panthenol
    Glycerin
    Butylene Glycol
    Caprylyl Glycol
    Madecassoside
    Salicylic Acid
    1,2-Hexanediol
    Ethylhexylglycerin

  • PURPOSE

    acne patch

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children

  • INDICATIONS & USAGE

    1. After cleansing, keep your skin clearly.

    2. Carefully remove dots from the film.

    3. Stick the patch to target areas of concern and gently press down on the patch for 2-3 minutes.

    4. Leave in place for 2 hours or more.(Use it during the day or night)

  • 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
    HARUTO BEAUTY MICRONEEDLE ACNE PIMPLEPATCH 
    sodium hyaluronate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71184-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM0.4298 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71184-0002-13 mg in 1 PATCH; Type 0: Not a Combination Product05/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/17/2020
    Labeler - Small Lab Co., Ltd. (688438425)
    Registrant - Small Lab Co., Ltd. (688438425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Small Lab Co., Ltd.688438425manufacture(71184-0002)