OILY SK BALANCING I (SALICYLIC ACID) CREAM [LABORATORIOS DE COSMETICA SCIENTIFI]

OILY SK BALANCING I (SALICYLIC ACID) CREAM [LABORATORIOS DE COSMETICA SCIENTIFI]
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NDC 75870-009-01, 75870-009-02
Set ID bbd72566-c027-4ae1-8de6-8e310d9ad728
Category HUMAN OTC DRUG LABEL
Packager LABORATORIOS DE COSMETICA SCIENTIFI
Generic Name
Product Class
Product Number
Application Number PART333D
  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 1%

  • PURPOSE

    Purpose:  Acne Treatment

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Uses:  Daily treatment cream for acne-prone skin.

  • WARNINGS

    Warnings:

    • For external use only.
    • Avoid contact with eyes and mucous membranes.
    • Discontinue use if signs of rash or irrigation appear.
  • DOSAGE & ADMINISTRATION

    Directions:  Apply a dime size amount to cleansed skin with a light massage.  Use morning and night.

  • INACTIVE INGREDIENT

    Other Ingredients:  WATER, HYDROGENATED POLYDECENE, ALCOHOL DENAT., BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, DIMETHICONE, CETYL ALCOHOL, GLYCERIN, MAGNESIUM ALUMINUM SULFATE, ZINC PCA, CAPRYLOYL GLYCINE, METHYL METHACRYLATE CROSSPOLYMER, MALIC ACID, SODIUM SALICYLATE, BISABOLOL, XANTHAN GUM, ENANTIA CHLORANTHA BARK EXTRACT, PLANTAGO LANCEOLATA LEAF EXTRACT, HYPERICUM PERFORATUM EXTRACT, OLEANOLIC ACID, HYDROLYZED SWEET ALMOND PROTEIN, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, MENTHA PIPERITA (PEPPERMINT) OIL, BERBERIS AQUIFOLIUM EXTRACT, POLYSORBATE 80, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, SODIUM HYDROXIDE.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    OILY SK BALANCING I 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.5 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SULFURIC ACID (UNII: O40UQP6WCF)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    MAHONIA AQUIFOLIUM FRUITING TOP (UNII: P119855ERN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
    PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
    HYPERICUM PERFORATUM LEAF (UNII: DOC7OB843Y)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    ALMOND (UNII: 3Z252A2K9G)  
    LEMON OIL (UNII: I9GRO824LL)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MAHONIA AQUIFOLIUM FRUITING TOP (UNII: P119855ERN)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75870-009-021 in 1 CARTON
    1NDC:75870-009-0150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/15/2007
    Labeler - LABORATORIOS DE COSMETICA SCIENTIFI (467582193)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE 467582193manufacture

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