Sebobalance Purifying Sebo-absorbing Mask
FDA Label NDC 62499-535

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoire Dr. Renaud for the product Sebobalance Purifying Sebo-absorbing Mask (NDC 62499-535). 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 active ingredient, inactive ingredients, otc - purpose, directions, warnings, package label.principal display panel, indications & usage, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Salicylic Acid 1% w/w.

Inactive Ingredients

WATER/EAU • HECTORITE • BUTYLENE GLYCOL • SORBITOL • KAOLIN • MAGNESIUM ALUMINIUM SILICATE • ZINC OXIDE • PEG-40 HYDROGENATED CASTOR OIL • LACTIC ACID • XANTHAN GUM • ALMOND (PRUNUS AMYGDALUS DULCIS) OIL • ROSEMARY (ROSMARINUS OFFICINALIS) OIL • SAGE (SALVIA OFFICINALIS) OIL SPANISH • LAVANDIN (LAVANDULA LATIFOLIA) OIL • COLEUS FORSKOHLII OIL • GALANGAL (KAEMPFERIA GALANGA) EXTRACT • CHAMOMILE (ANTHEMIS NOBILIS) OIL • PEG-60 ALMOND GLYCERIDES • CAPRYLYL GLYCOL • CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL • NORDIHYDROGUAIARETIC ACID • OLEANOLIC ACID • ALLANTOIN • GLYCERIN • PHENOXYETHANOL • ETHYLHEXYLGLYCERIN • CARBOMER •

Otc - Purpose

For the treatment of acne and allows skin to heal.

Directions

Once or twice a week, aftera thorough cleansing of the skin, apply evenlyand sparingly to the face and the neck.Pause for 20 minutes. Rinse liberally first withlukewarm water, then with cold.

Warnings

For external use only.Using other topical acne medications at the sametime or immediately following use of this productmay increase dryness or irritation of the skin.If this occurs, only one medication should beused unless directed by a doctor. Avoiddirect contact with the eyes. If product getsinto the eyes, rinse liberally with water.Discontinue use if skin irritation develops orincreases. If irritation persists, consult a doctor.

Package Label.Principal Display Panel

Image of carton 60g labelimage of tube 200g labelimage of tube 60g label

Indications & Usage

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Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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