Label: SUPER SPOT REMOVER ACNE TREATMENT- salicylic acid gel

  • NDC Code(s): 59427-005-01
  • Packager: ORIGINS NATURAL RESOURCES INC.
  • 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 09/12

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Salicylic Acid 1.50%

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  • Purpose

    Acne treatment

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  • Uses

    • For the treatment of acne
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  • Warnings

    For external use only.

    Avoid eye area.

    Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    Keep out of reach of children. If swallowed, call a doctor or contact a Poison Control Center right away.

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  • Directions

    • Cleanse skin.
    • Apply a thin layer 1 to 3 times daily or as needed.
    • If dryness or peeling occurs, reduce application to every other day.
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  • Inactive ingredients

    water\aqua\eau • alcohol denat. • acrylates/c10-30 alkyl acrylate crosspolymer • hamamelis virginiana (witch hazel) • eugenia caryophyllus (clove) bud oil1, origanum heracleoticum flower oil1, eugenol, limonene • cucumis sativus (cucumber) fruit extract • pyrus malus (apple) fruit extract • scutellaria baicalensis root extract • algae extract • poria cocos sclerotium extract • laminaria saccharina extract • lactobacillus ferment • glycerin • caffeine • butylene glycol • tocopheryl acetate • magnesium ascorbyl phosphate • sodium hydroxide • phenoxyethanol <iln37864>


    1
    essential oil
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  • SPL UNCLASSIFIED SECTION

    © Origins Nat. Res., Dist.
    New York, NY 10022

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  • PRINCIPAL DISPLAY PANEL - 10 ml Carton

    ORIGINS

    Super Spot
    Remover

    Acne treatment gel
    salicylic acid

    .3 fl. oz./oz. liq./
    10 ml e

    Principal Display Panel - 10 ml Carton
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  • INGREDIENTS AND APPEARANCE
    SUPER SPOT REMOVER ACNE TREATMENT 
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59427-005
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    witch hazel  
    clove oil  
    eugenol  
    cucumber  
    apple  
    scutellaria baicalensis root  
    saccharina latissima  
    glycerin  
    caffeine  
    butylene glycol  
    .alpha.-tocopherol acetate  
    magnesium ascorbyl phosphate  
    sodium hydroxide  
    phenoxyethanol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59427-005-01 1 in 1 CARTON
    1 10 mL in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 04/01/2012
    Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
    Establishment
    Name Address ID/FEI Business Operations
    ELGC K.K. 712808195 RELABEL(59427-005), REPACK(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    Estee Lauder Inc. 042918826 MANUFACTURE(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(59427-005), RELABEL(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    NORTEC KEYSTONE 943871157 MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC BRISTOL 959338336 MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    NORTHTEC KEYSTONE 949264774 MANUFACTURE(59427-005), RELABEL(59427-005), REPACK(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    Aveda Corporation 071352058 MANUFACTURE(59427-005)
    Establishment
    Name Address ID/FEI Business Operations
    Pennsylvania Logistics Center 078364654 REPACK(59427-005), RELABEL(59427-005)
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