Active Ingredient
ACTIVE INGREDIENT: DIMETHICONE 1.80%
Rovectin
FDA Label NDC 52970-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Second Formula Inc. for the product Rovectin (NDC 52970-010). 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 ingredient, purpose, warnings, keep out of reach of children, indications and usage, dosage and administration, package label. principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
INACTIVE INGREDIENTS:
WATER, CYCLOPENTASILOXANE, BUTYROSPERMUM PARKII (SHEA BUTTER), HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, NIACINAMIDE, GLYCERIN, SQUALANE, CETEARYL METHICONE, PHENOXYETHANOL, RICINUS COMMUNIS (CASTOR) SEED OIL, PERSEA GRATISSIMA (AVOCADO) OIL, OLIVE GLYCERIDES, HEXYLDECANOL, POLYSORBATE 60, LINOLEIC ACID, GLYCINE SOJA (SOYBEAN) STEROLS, PHOSPHOLIPIDS, ALOE BARBADENSIS LEAF JUICE, HYDROXYETHYLCELLULOSE, ETHYLHEXYLGLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM PHYTATE, TOCOPHEROL, CERAMIDE 3, SODIUM HYDROXIDE, HAEMATOCOCCUS PLUVIALIS EXTRACT
Purpose
PURPOSE: SKIN PROTECTANT
Warnings
WARNINGS:
FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES.
STOP USE AND ASK A DOCTOR IF CONDITION WORNSENS.
DO NOT USE ON DEEP OR PUNCTURE WOUNDS.
KEEP OUT OF THE REACH OF CHILDREN.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Indications And Usage
Directions:
Apply to face, neck, hands, feet and body.
Use as often as necessary.
Dosage And Administration
Directions:
Apply to face, neck, hands, feet and body.
Use as often as necessary.
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