Label: FRESH MED SOLUTION - glycerin, alcohol and glyceryl monostearate liquid 

  • NDC Code(s): 52257-1100-1, 52257-1100-2
  • Packager: ATOMY CO LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/11

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  • Drug Facts

    Active Ingredient

    Glycerin                 4.36%

    Alcohol                  4.000%

    Glyceryl Stearate    1.000%

    Purpose

    Skin Protectant

    Keep out of Reach of Children

    Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away

    Indication & Usage

    Directions

    Gently cleanse and dry area.

    Apply liberally to affected area as needed.

    Children under 6 months: ask a doctor

    Warnings

    For external use only
    Avoid contact with eyes.
    Do not apply to deep or puncture wounds.
    If condition worsens, or does not improve within 7 days, consult a doctor.
    Do not use
    areas of eczema, skin inflammation, or after injury
    When using this product
    Keep out of eyes
    Rinse with water to remove
    Discontinue use if irritation or rash appear
    Ask a doctor before use if you have
    Irritated skin
    Any area that is infected or reddened
    Diabetes
    Poor blood

    Dosage & Administration

    Uses

    Temporarily protects and helps relieve chapped or cracked skin

    Helps protect from the drying effects of wind and cold weather

    Inactive Ingredient

    Citrus unshiu fruit oil, Althaea officinalis leaf/root extract, Anthemis nobilis flower extract, Centella asiatica extract, Foeniculum vulgare(fennel) fruit extract, Houttuynia cordata extract, Lavandula angustifolia(lavender) flower extract, Ocimum basilicum(basil) flower/leaf extract, Portulaca oleracea extract, Rosmarinus officinalis(rosemary) leaf extract, Caprylic/capric glycerides, Macadamia ternifolia seed oil, Hydrogenated lecithin, Cetearyl alcohol, Sodium ascorbyl phosphate, Disodium EDTA

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  • Fresh Med Solution

    ATOMY Fresh Med Solution

    Net WT. 1.3 FL OZ(40ml)

    image of carton label

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  • INGREDIENTS AND APPEARANCE
    FRESH MED SOLUTION 
    glycerin, alcohol, glyceryl monostearate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52257-1100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (GLYCERIN) GLYCERIN 1.744 mL  in 40 mL
    ALCOHOL (ALCOHOL) ALCOHOL 1.6 mL  in 40 mL
    GLYCERYL MONOSTEARATE (GLYCERYL MONOSTEARATE) GLYCERYL MONOSTEARATE 0.4 mL  in 40 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRUS RETICULATA FRUIT OIL  
    ALTHAEA OFFICINALIS LEAF  
    CHAMAEMELUM NOBILE FLOWER  
    CENTELLA ASIATICA  
    BITTER FENNEL  
    HOUTTUYNIA CORDATA FLOWERING TOP  
    LAVANDULA ANGUSTIFOLIA FLOWER  
    OCIMUM BASILICUM FLOWERING TOP  
    PORTULACA OLERACEA WHOLE  
    ROSEMARY  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES  
    MACADAMIA OIL  
    HYDROGENATED SOYBEAN LECITHIN  
    CETOSTEARYL ALCOHOL  
    SODIUM ASCORBYL PHOSPHATE  
    EDETATE DISODIUM  
    ALTHAEA OFFICINALIS ROOT  
    Product Characteristics
    Color white (white blue) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52257-1100-2 1 in 1 BOX
    1 NDC:52257-1100-1 40 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 07/18/2011
    Labeler - ATOMY CO LTD (631154601)
    Registrant - ATOMY CO LTD (631154601)
    Establishment
    Name Address ID/FEI Business Operations
    ATOMY CO LTD 631154601 relabel
    Establishment
    Name Address ID/FEI Business Operations
    KOLMAR KOREA CO LTD 687846360 manufacture
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