Label: OSEA BLEMISH BALM- salicylic acid cream

  • NDC Code(s): 73432-002-01, 73432-002-02
  • Packager: OSEA International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 1%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Clears up acne pimples and allows skin to heal
    • Helps prevent new acne pimples, blackheads and whiteheads from forming
  • Warnings

    For external use only.

    When using this product

    • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • Keep out of eyes. Rinse with water to remove.

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

  • Directions

    • Clean the skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer one to two times daily
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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

    Sensitivity Test for a New User

    Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

  • Inactive ingredients

    WATER, TRIHEPTANOIN, HYDROGENATED ETHYLHEXYL OLIVATE, CETEARYL OLIVATE, PROPANEDIOL, GLYCERIN, DIHEPTYL SUCCINATE, SORBITAN OLIVATE, CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER, CITRUS PARADISI (Grapefruit) PEEL OIL, LAVANDULA ANGUSTIFOLIA (Lavender) OIL, GIGARTINA STELLATA/ KAPPAPHYCUS ALVAREZII EXTRACT, CORALLINA OFFICINALIS EXTRACT, FUCUS SPIRALIS EXTRACT, TETRASELMIS CHUI EXTRACT, SIMMONDSIA CHINENSIS (Jojoba) SEED OIL, VITIS VINIFERA (Grape) SEED OIL, HYDROGENATED OLIVE OIL UNSAPONIFIABLES, CAMELINA SATIVA SEED OIL, THYMUS VULGARIS (Thyme) FLOWER/LEAF/STEM WATER, TOCOPHEROL, BACKHOUSIA CITRIODORA LEAF EXTRACT, CITRUS AURANTIFOLIA (Lime) OIL, CITRUS NOBILIS (Mandarin Orange) PEEL OIL, CUPRESSUS SEMPERVIRENS OIL, EUCALYPTUS GLOBULUS LEAF OIL, JUNIPERUS VIRGINIANA OIL, LAVANDULA HYBRIDA OIL, LIMONENE, MENTHA PIPERITA (Peppermint) OIL, MENTHA VIRIDIS (Spearmint) EXTRACT, PELARGONIUM GRAVEOLENS FLOWER OIL, PRUNUS AMYGDALUS DULCIS (Sweet Almond) OIL, ROSMARINUS OFFICINALIS (Rosemary) LEAF OIL, THYMUS VULGARIS (Thyme) OIL, LONICERA JAPONICA (Honeysuckle) FLOWER EXTRACT, LONICERA CAPRIFOLIUM (Honeysuckle) FLOWER EXTRACT, SODIUM STEAROYL GLUTAMATE, BENTONITE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, XANTHAN GUM, SODIUM HYDROXIDE, CITRIC ACID, POTASSIUM SORBATE

  • SPL UNCLASSIFIED SECTION

    Dist. by
    OSEA Intl. LLC
    Malibu, CA 90265

  • PRINCIPAL DISPLAY PANEL - 60 ml Bottle Carton

    OSEA

    blemish
    balm

    1% salicylic acid
    acne treatment

    2 fl. oz. / 60 ml

    PRINCIPAL DISPLAY PANEL - 60 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    OSEA BLEMISH BALM 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73432-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Triheptanoin (UNII: 2P6O7CFW5K)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Mastocarpus stellatus (UNII: 6T087FC66H)  
    Kappaphycus alvarezii (UNII: T479H08K2O)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    FUCUS SPIRALIS (UNII: 3W9AY2P26F)  
    TETRASELMIS CHUI (UNII: T9C83Z6363)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
    CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
    THYME (UNII: CW657OBU4N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
    LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)  
    MANDARIN OIL (UNII: NJO720F72R)  
    CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    THYME OIL (UNII: 2UK410MY6B)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    BENTONITE (UNII: A3N5ZCN45C)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73432-002-011 in 1 CARTON10/01/2023
    160 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:73432-002-021 in 1 CARTON10/01/2023
    218 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2023
    Labeler - OSEA International, LLC (015193384)
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