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Product NDC Code | 35192-029 | ||||
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Drug Name | Skin protectant |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M016 | ||||
Labeler Name | CA-Botana International | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Aluminum acetate 0.2%
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.use 3 times to[pically
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Cetyl Alcohol, Dimethico 100, Polyacrylic Acid, Polawax Polysorbate, Glycerin, Caprylyl Glycol, Ceramide NG, Water, Magnesium Aluminum Silicate, Glyceryl Stearate, Edenate Disodium, Tocopherol, Tetrahexyldecyl Ascorbate, Shea Butter, Phenoxyethanol, Strontium Nitrate, Xanthan Gum Hyaloronic acid, Stearyl Alcohol, IsopropyylMyrristate, Caprylic/Capric Tryglyceride
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.For external use only Avoid contact with eyes Do not apply to open wound Stop use and ask a doctor if condition worsens or symtomps persist for more than seven days Keep out reach of children
Purpose
Information about the drug product’s indications for use.Relieves minor skin irritations due to poison Ivi. Poison oak. Poison sumac. Insect bites Athlete's foot. Allergic itches. Irritations
Spl product data elements
Usually a list of ingredients in a drug product.Skin protectant Astrigent ALUMINUM ACETATE ALUMINUM CATION XANTHAN GUM CAPRYLYL GLYCOL CERAMIDE NG WATER O-18 MAGNESIUM ALUMINUM SILICATE TYPE IA GLYCERYL STEARATE SE EDETATE DISODIUM TOCOPHEROL TETRAHEXYLDECYL ASCORBATE SHEA BUTTER PHENOXYETHANOL STRONTIUM NITRATE ISOPROPYL MYRISTATE CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES CETYL ALCOHOL DIMETHICONE 100 POLYACRYLIC ACID (450000 MW) HYALURONIC ACID STEARYL ALCOHOL POLAWAX POLYSORBATE GLYCERIN
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.label Dermaleve Cream Tube artwork.jpg
Instructions for use
Information about safe handling and use of the drug product.Directions: Adults and childrens tho years of age and older apply to affected area as needed or as directed by a doctor. Consult a doctor for children under the age of two
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
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.For external use only. Avoid contact with eyes. Do not apply to open wounds. S TOP USE and ask a doctor if condition worsens or symtomps persist for more than seven days. Keep out reach of children
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