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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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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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
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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
- PRINCIPAL DISPLAY PANEL - 60 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
OSEA BLEMISH BALM
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73432-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 1 mg in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73432-002-01 1 in 1 CARTON 10/01/2023 1 60 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 2 NDC:73432-002-02 1 in 1 CARTON 10/01/2023 2 18 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/01/2023 Labeler - OSEA International, LLC (015193384)