PURIFACE HYDROGEL CLEANSING FOAM (SALICYLIC ACID) GEL [IMODE KOREA, INC.]

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PURIFACE HYDROGEL CLEANSING FOAM (SALICYLIC ACID) GEL [IMODE KOREA, INC.]
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NDC 71727-105-01, 71727-105-02
Set ID 8168ab9c-b55c-d39f-e053-2991aa0ad7fd
Category HUMAN OTC DRUG LABEL
Packager iMode Korea, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
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  • Active ingredients

    salicylic acid 0.01%

  • Purpose

    Acne Treatment

  • Uses

    Sebum control

  • Warnings

    Warnings

    For external use only

    Do not use when

    skin is red, inflamed, irritated, or painful

    When using this product

    § skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

    § avoid contact with eyes. If contact occurs, flush thoroughly with water.

    Stop use and ask a doctor if

    § Rash or irritation on skin develops and lasts

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Wet face. Apply to hands, add water and work into a lather. Gently massage all over face avoiding eye area. Rinse thoroughly and pat dry.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Inactive ingredients

    Water, Stearic Acid, Glycerin, Myristic Acid, Lauric Acid, Potassium Hydroxide, Beeswax, Glyceryl Stearate, Glycol Stearate, Glycol Distearate, Sodium Chloride, Lavandula Angustifolia (Lavender) Oil, Allantoin, Beta-Glucan, Butylene Glycol, Lavandula Angustifolia (Lavender) Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Xanthan Gum, Ceratonia Siliqua (Carob) Gum, Sucrose, Carrageenan, Potassium Chloride, Gellan Gum, Cellulose Gum, Propanediol, Pentylene Glycol, Cocos Nucifera (Coconut) Fruit Extract, Pinus Sylvestris Leaf Extract, Sodium Hyaluronate, 1,2-Hexanediol, Arginine, Disodium EDTA, Citric Acid, Sodium Citrate, Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Hexylene Glycol, Hydroxyacetophenone, Caprylyl Glycol, Ethylhexylglycerin.

  • Puriface Hydrogel Cleansing Foam

    hydrogel foam draft label with drug facts

  • INGREDIENTS AND APPEARANCE
    PURIFACE HYDROGEL CLEANSING FOAM 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71727-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.012 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71727-105-021 in 1 BOX02/08/2019
    1NDC:71727-105-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/08/2019
    Labeler - iMode Korea, Inc. (694627846)
    Registrant - iMode Korea, Inc. (694627846)
    Establishment
    NameAddressID/FEIBusiness Operations
    JINCOSTECH Co., Ltd.688484870manufacture(71727-105)
    Establishment
    NameAddressID/FEIBusiness Operations
    iMode Korea, Inc.694627846relabel(71727-105)
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