Sebobalance Spot Control
FDA Label NDC 62499-384

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 Spot Control (NDC 62499-384). 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, otc - keep out of reach of children, indications & usage, 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 • ALCOHOL DENAT • SORBITOL • METHYL GLUCETH 20 • GLYCOLIC ACID • GLYCERIN •ALPHA-GLUCAN OLIGOSACCHARIDE • SODIUM CITRATE • BUTYLENE GLYCOL • PROPYLENE GLYCOL • SODIUM HYDROXIDE • AMYLOPECTIN • XANTHAN GUM • DEXTRIN • HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT • ARGININE • CELLULOSE GUM • ALLANTOIN • PEUMUS BOLDUS LEAF EXTRACT • ASCOPHYLLUM NODOSUM EXTRACT • ANTHEMIS NOBILIS FLOWER EXTRACT • CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT • CENTAUREA CYANUS FLOWER EXTRACT • TILIA VULGARIS FLOWER EXTRACT • CALENDULA OFFICINALIS FLOWER EXTRACT • HYPERICUM PERFORATUM EXTRACT • ASPARAGOPSIS ARMATA EXTRACT • ETHYLHEXYLGLYCERIN • PHENOXYETHANOL •

Otc - Purpose

For the treatment of acne. Dries and clears acne pimples, blackheads and whiteheads and allows skin to heal.

Directions

Morning and evening, after a thorough cleansing of the skin, apply SeboBalance Spot ControlGel locally on cutanous imperfections. Then apply the usual day or night cream. Renew application 1 to 3 times daily.

Warnings

For external use only. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Avoid direct contact with the eyes. If product gets into the eyes, rinse liberally with water. Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor. This product contains alpha-hydroxy-acids (AHA) which may increase sensitivity to the sun and lead to skin burn. Reduce sun exposure and use a sunblock during the use of this product and the week following its use.

Package Label.Principal Display Panel

Image of carton labelImage of bottle label

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

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