Label: AC CONTROL SERUM- allantoin 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 February 18, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.2%

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Lavandula angustifolia (Lavender) flower extract, Alcohol, Lavandula angustifolia (Lavender) extract, Rosmarinus officinalis (Rosemary) extract, Thymus vulgaris (Thyme) extract, Mentha arvensis leaf extract, Borago officinalis extract, Salvia officinalis (Sage) leaf extract, Jasminum officinale (Jasmine) extract, Anthemis nobilis flower extract, Eclipta prostrata extract, Rehmannia glutinosa root extract, Artemisia princeps leaf extract, Portulaca oleracea extract, Glycyrrhiza glabra (Licorice) root extract, Butylene glycol, Sodium hyaluronate, Lonicera japonica(Honeysuckle) flower extract, Zanthoxylum piperitum fruit extract, Pulsatilla koreana extract, Citrus paradisi(Grapefruit) fruit extract, Citrus aurantium dulcis(Orange) fruit extract, Citrus medica limonum(Lemon) fruit extract, Pyrus malus(Apple) fruit extract, Dimethyl sulfone, Glycosyl trehalose, Hydrogenated starch hydrolysate, Arginine, Carbomer, PEG-60 hydrogenated castor oil, Menthol, Disodium EDTA, Rosmarinus officinalis (Rosemary) leaf oil

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  • PURPOSE

    Purpose: Skin Protectant

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  • WARNINGS

    Warnings:

    1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • Usage

    Usage: An appropriate amount and evenly apply it on the face along the skin texture.

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  • Usage

    Usage: An appropriate amount and evenly apply it on the face along the skin texture.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    AC CONTROL SERUM 
    allantoin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70380-070
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.1 g  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70380-070-01 50 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/02/2016
    Labeler - MIGUHARA (689204213)
    Registrant - MIGUHARA (689204213)
    Establishment
    Name Address ID/FEI Business Operations
    MIGUHARA 689204213 manufacture(70380-070)
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