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Calming Skin (ATOMY CO LTD)

Available Formats

Dosage Form Package Information Links
LOTION 1 BOTTLE in 1 BOX (52257-1110-2) > 130 mL in 1 BOTTLE (52257-1110-1) Label Information

Complete Calming Skin Information

  • Drug Facts

    Active ingredient
    Vitamin E 0.500%
    Glycerin    0.500%
    Panthenol 0.500%

    Purpose

    Acne treatment and skin protectant

    Keep out of Reach of Children Stop use and ask a doctor if
    too much skin irritation or sensitivity develops or increases.

    Keep out of reach of children
    if swallowed, get medical help or contact a Poison Control Center right away.

    Indication & Usage

    Directions
    Clean the skin thoroughly before applying.
    Cover the entire affected area with a thin layer 1 to 3 times daily.
    Because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
    If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, use a sunscreen, and then follow directions in the sunscreen labeling.

    Warnings

    Warnings

    For external use only.
    Do not use on broken skin, on large areas of the body.
    When using this product apply to affected areas only, avoid unnecessary sun exposure and use a sunscreen, do not use in or near the eyes, using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of th skin, only one drug should be used unless directed by a doctor.

    Dosage & Administration


    Uses
    Treats acne. Dries up acne pimples. Helps prevent new acne pimples.

    Inactive Ingredient

    Althaea officinalis leaf/root extract, Anthemis nobilis flower 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, Centella asiatica extract, 1,2-Hexanediol, Phellinus linteus extract, Ceramide 3, Citrus unshiu fruit oil, Hydrogenated lecithin, Macadamia ternifolia seed oil, Retinyl palmitate, Glyceryl stearate, Ubiquinone, Disodium EDTA, Sodium ascorbyl phosphate


  • Calming skin

    ATOMY Calming skin

    Net WT. 4.39 FL OZ(130ml)

    image of carton label


  • INGREDIENTS AND APPEARANCE
    CALMING SKIN  
    panthenol, glycerin, tocopherol lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52257-1110
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.65 mL  in 130 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.65 mL  in 130 mL
    TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL 0.65 mL  in 130 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    BITTER FENNEL (UNII: J5W36Y5WG8)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    ROSEMARY (UNII: IJ67X351P9)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PHELLINUS LINTEUS WHOLE (UNII: YVO92B1UCA)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52257-1110-2 1 in 1 BOX
    1 NDC:52257-1110-1 130 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 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