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|Product NDC Code||74721-0100|
|Labeler Name||S-ONE PHARMACEUTICAL INC|
Active ingredientA list of the active, medicinal ingredients in the drug product.
Active ingredients - Xanthium Strumarium Fruit Extract 10%(w/w) - Canavalia Gladiata Extract 5%(w/w)
Dosage and administrationInformation 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.
Use It is a cream made by using xanthium strumarium fruit extract as the main ingredient and helps various skin problems.
Inactive ingredientA list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Petrolatum, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Cetyl Alcohol, Polysorbate 60, Beeswax, Aloe Arborescens Leaf Extract, Glyceryl Stearate, Butyrospermum Parkii (Shea)Butter, Hyaluronic Acid, Citric Acid, Polylysine, Glycerin
Indications and usageA 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.
Directions 1) Wash your hands and feet with clean foot soap and use a towel and dryer to completely remove moisture 2) After applying this product thickly to the nails or toenails you want to use, attach it using a gauze or a disposable band to prevent the cream from being lost to the outside.
PurposeInformation about the drug product’s indications for use.
Purpose Hand & Feet skin softening product
Spl product data elementsUsually a list of ingredients in a drug product.
SSEUG SSAGCREAM Xanthium Strumarium Fruit Extract, Canavalia Gladiata Extract PETROLATUM CETYL ALCOHOL SHEA BUTTER GLYCERIN CANAVALIA GLADIATA WHOLE CANAVALIA GLADIATA WHOLE XANTHIUM STRUMARIUM FRUIT XANTHIUM STRUMARIUM FRUIT OLIVE OIL PROPYLENE GLYCOL GLYCERYL STEARATE SE CITRIC ACID MONOHYDRATE POLYSORBATE 60 YELLOW WAX ALOE VERA LEAF HYALURONIC ACID WATER POLY-L-LYSINE (30000-70000 MW)
Package label principal display panelThe 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.
Package Label 74721-0100-1
Do not useInformation 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 Do not use it if you have red spots, swelling, itching or irritation on skin during use Do not use it if the area of application is abnormal due to direct sunlight. Do not use this product on skin with wounds or bleeding. Do not use eat this product, and if ingested, consult a specialist immediately. Do not use it for anything other than its purpose. If it gets in your eyes, rinse it with water immediately.
Keep out of reach of childrenInformation 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 the reach of children. Keep out of the reach of children.
Storage and handlingInformation about safe storage and handling of the drug product.
Other Information Avoid hot or cold places or in direct sunlight.
WarningsInformation 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. Make sure to close the cap after use.
Disclaimer: Do not rely on openFDA 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