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| Product NDC Code | 73432-002 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Osea blemish balm |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | part333D | ||||||
| Labeler Name | OSEA International, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic Acid 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.OSEA Blemish Balm Salicylic Acid Salicylic Acid Salicylic Acid water Triheptanoin CETEARYL OLIVATE PROPANEDIOL GLYCERIN DIHEPTYL SUCCINATE SORBITAN OLIVATE CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) GRAPEFRUIT OIL LAVENDER OIL Mastocarpus stellatus Kappaphycus alvarezii CORALLINA OFFICINALIS FUCUS SPIRALIS TETRASELMIS CHUI JOJOBA OIL GRAPE SEED OIL HYDROGENATED OLIVE OIL UNSAPONIFIABLES CAMELINA SATIVA SEED OIL THYME TOCOPHEROL BACKHOUSIA CITRIODORA LEAF LIME OIL, COLD PRESSED MANDARIN OIL CUPRESSUS SEMPERVIRENS LEAF OIL EUCALYPTUS OIL JUNIPERUS VIRGINIANA OIL LAVANDIN OIL LIMONENE, (+)- PEPPERMINT OIL SPEARMINT PELARGONIUM GRAVEOLENS FLOWER OIL ALMOND OIL ROSEMARY OIL THYME OIL LONICERA JAPONICA FLOWER LONICERA CAPRIFOLIUM FLOWER SODIUM STEAROYL GLUTAMATE BENTONITE TRISODIUM ETHYLENEDIAMINE DISUCCINATE XANTHAN GUM SODIUM HYDROXIDE CITRIC ACID MONOHYDRATE POTASSIUM SORBATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Dist. by OSEA Intl. LLC Malibu, CA 90265
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API