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Shiseido synchro skin self-refreshing foundation 540 mahogany - Medication Information

Product NDC Code 58411-511
Drug Name

Shiseido synchro skin self-refreshing foundation 540 mahogany

Type Brand
Active Ingredients
Octinoxate 1.69 g/30ml
Titanium dioxide .345 g/30ml
Route TOPICAL
Dosage Form EMULSION
Application Number part352
Labeler Name SHISEIDO AMERICAS CORPORATION
Packages
Package NDC Code Description
58411-511-10 1 bottle in 1 carton (58411-511-10) / 30 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Purpose Octinoxate 4.9% Sunscreen Titanium Dioxide 1% Sunscreen
Active ingredients Purpose
Octinoxate 4.9% Sunscreen
Titanium Dioxide 1% Sunscreen

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 For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients DIMETHICONE • WATER • GLYCERIN • TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE • PHENYL TRIMETHICONE • PEG-10 DIMETHICONE • BUTYLENE GLYCOL • DIMETHICONE CROSSPOLYMER • BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 • SORBITAN SESQUIISOSTEARATE • ISOPROPYL MYRISTATE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • NACRE POWDER • MAGNESIUM ALUMINOMETASILICATE • POLYQUATERNIUM-51 • THYMUS SERPYLLUM EXTRACT • SODIUM ACETYLATED HYALURONATE • CYCLOPENTASILOXANE • DISTEARDIMONIUM HECTORITE • POLYSILICONE-2 • POLYMETHYLSILSESQUIOXANE • TRIMETHYLSILOXYSILYLCARBAMOYL PULLULAN • ALUMINUM HYDROXIDE • STEARIC ACID • LITHIUM MAGNESIUM SODIUM SILICATE • PEG/PPG-19/19 DIMETHICONE • CITRIC ACID • SODIUM CITRATE • BHT • SILICA • TOCOPHEROL • PHENOXYETHANOL • IRON OXIDES • TITANIUM DIOXIDE • MICA •

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 helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Information about the drug product’s indications for use.
Active ingredients Purpose Octinoxate 4.9% Sunscreen Titanium Dioxide 1% Sunscreen
Active ingredients Purpose
Octinoxate 4.9% Sunscreen
Titanium Dioxide 1% Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 440 AMBER OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 450 COPPER OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 460 TOPAZ OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 510 SUEDE OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 520 ROSEWOOD OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 530 HENNA OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 550 JASPER OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN OCTINOXATE and TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE WATER GLYCERIN PHENYL TRIMETHICONE PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) SORBITAN SESQUIISOSTEARATE ISOPROPYL MYRISTATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILODRATE POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM SODIUM ACETYLATED HYALURONATE CYCLOMETHICONE 5 DISTEARDIMONIUM HECTORITE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ALUMINUM HYDROXIDE STEARIC ACID LAPONITE PEG/PPG-19/19 DIMETHICONE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM BUTYLATED HYDROXYTOLUENE SILICON DIOXIDE .ALPHA.-TOCOPHEROL PHENOXYETHANOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA

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 - 30 mL Bottle Carton - 430 Cedar SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 430 Cedar PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 440 Amber SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 440 Amber PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 450 Copper SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 450 Copper PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 460 Topaz SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 460 Topaz PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 510 Suede SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 510 Suede PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 520 Rosewood SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 520 Rosewood PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 530 Henna SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 530 Henna PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 540 Mahogany SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 540 Mahogany PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 550 Jasper SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 550 Jasper PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 560 Obsidian SHISEIDO GINZA TOKYO SYNCHRO SKIN SELF-REFRESHING Foundation Oil-Free BROAD SPECTRUM SPF 30 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 560 Obsidian

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

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call toll free 1-800-906-7503

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs.

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 keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Protect this product in this container from excessive heat and direct sun.

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 Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is 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