Osea Blemish Balm
FDA Label NDC 73432-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Osea International, Llc for the product Osea Blemish Balm (NDC 73432-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by
OSEA Intl. LLC
Malibu, CA 90265

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.

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (60 ml Bottle Carton)

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