Label: DERMACLEAR SERUM- salicylic acid cream

  • NDC Code(s): 62742-4069-1, 62742-4069-2
  • Packager: Allure Labs 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 November 26, 2020

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

  • ACTIVE INGREDIENT

    Active Ingredients: Salicylic Acid 2%

  • PURPOSE

    Purpose: Acne Treatment

  • INDICATIONS & USAGE

    Uses:

    For the treatment of acne

  • WARNINGS

    Warnings:

    For external use only.

  • WHEN USING

    When Using this product: Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

  • STOP USE

    If irritation occurs, only use one topical acne medication at a time.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the skin thoroughly before before applying this product.
    • Cover the entire affected area with a thin layer one to three times daily.
    • Because excessive drying of the skin may occur, stsart with one application daily, then gradually increase to two or three times daily if needed or as directed vy doctor.
    • If bothersome dryness or peeling occurs, reduce applicaiton to ince a day or every other day.
    • Sensitivity Test for a new users. Apply product sparingly to one or two small affected areas during first 3 days. If no discomfort occurs, follwo the directions atated above.
  • OTHER SAFETY INFORMATION

    Other Information:

    Protect the product in this container from the excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Water (Aqua), Alcohol Denat., Glycolic Acid, Caprylic / Capric Triglyceride, Azelaic Acid, Glycerin, Hexyl Laurate, Cetearyl Alcohol, Cetearyl Olivate, Butylene Glycol, Sorbitol, Lactic Acid, Sorbitan Olivate, PPG-12 /SMDI Copolymer, Niacinamide, Cetyl Alcohol, Sodium Hyaluronate, Dicetyl Phosphate, Ceteth-10 Phosphate, Srearic Acid, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Mangifera Indiaca (Mango) Seed Butter, Dimethicone, Ethyl Linoleate, Hexylrsorcinol, Yeast Ploysaccharides, Propylene Glycol, Symphytum Officinales Rhizome/Root Extract, Plantago Ovata Seed Extract, Glutamine, Proline, Leucine, Serine, Hedera, Helix (Ivy) Leaf/Stem Extract, Cucumis Sativus Fruit Extract, Sambucus Nigra Flower Extract, Arnica Montana Flower Extract, Parietaria Officinalis Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Lavandula Angustifoia (Lavender) Oil, Imperata Cylindrica (Root) Extract, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Mellifolium Extract, Hydrolyzed Vegetable Protein, Glycosaminoglycans, Salix Alba (Willlow) Bark Extract, Arcaptostaphylos, Uva Ursi Leaf Extract, Mitracarpus Scaber Extract, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Oleanolic Acid. Glycerin, Hydrolyzed wheat Protein, Hydrolyzed Wheat Starch, Maltodextrin, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Xanthan Gum, Magnesium Aluminum Silicate, Ammonium Hydroxide, Disodium EDTA, Linalool

  • PRINCIPAL DISPLAY PANEL

    Manufactured for Dermaquest Inc
    Hayward, CA 94544
    1272 GK, NL Made in USA
    dermaquestinc.com

    IMGDERMSERUM

  • INGREDIENTS AND APPEARANCE
    DERMACLEAR SERUM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    YEAST (UNII: 3NY3SM6B8U)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITOL (UNII: 506T60A25R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLUTAMINE (UNII: 0RH81L854J)  
    LEUCINE (UNII: GMW67QNF9C)  
    SERINE (UNII: 452VLY9402)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    PARIETARIA OFFICINALIS LEAF (UNII: W2I83529KR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    PRIMULA VERIS (UNII: W6LFQ57E4M)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    HEXYLRESORCINOL (UNII: R9QTB5E82N)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    GAG (UNII: U5T7CTT5KM)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MITRACARPUS HIRTUS WHOLE (UNII: 57P5O8083D)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SYRINGA VULGARIS WHOLE (UNII: U49SHU1VCI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    AMMONIA (UNII: 5138Q19F1X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    PLANTAGO OVATA SEED (UNII: UD50RBY30F)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4069-21 in 1 CARTON05/30/2014
    1NDC:62742-4069-129.6 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/30/2014
    Labeler - Allure Labs Inc (926831603)
    Registrant - Allure Labs Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs Inc926831603manufacture(62742-4069)