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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 September 5, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 1.50%

  • Purpose

    Acne treatment

  • Uses

    • For the treatment of acne
  • 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.

  • 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.
  • Inactive ingredients

    water\aqua\eau • alcohol denat. • acrylates/c10-30 alkyl acrylate crosspolymer • hamamelis virginiana (witch hazel) • eugenia caryophyllus (clove) bud oil 1, origanum heracleoticum flower oil 1, 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
  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    SUPER SPOT REMOVER ACNE TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)  
    WATER (UNII: 059QF0KO0R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    CLOVE OIL (UNII: 578389D6D0)  
    EUGENOL (UNII: 3T8H1794QW)  
    CUCUMBER (UNII: YY7C30VXJT)  
    APPLE (UNII: B423VGH5S9)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAFFEINE (UNII: 3G6A5W338E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    FU LING (UNII: XH37TWY5O4)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59427-005-011 in 1 CARTON11/24/2020
    110 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00604/01/2012
    Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(59427-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(59427-005)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!