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| Product NDC Code | 59088-627 | ||||
|---|---|---|---|---|---|
| Drug Name | Zinctral |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 416684 | ||||
| Application Number | part347 | ||||
| Labeler Name | PureTek Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 20.0% (3.0% as Calamine) Purpose Skin Protectant
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 Cleanse skin with DiaSinc All Purpose Cleansing Spray and apply paste to area as needed. Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance (Contains: Alpha-Isomethyl Ionone, Butylphenyl Methylpropional, Coumarin, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool), GenRx Complex® [Consisting of: Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, DL-Alpha-Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract ], Petrolatum, Phenoxyethanol, Zea Mays (Corn) Starch.
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 dries the oozing and weeping of poison: ivy oak sumac Helps treat and prevent diaper rash. Protects minor skin irritations due to diaper rash and helps protect from wetness.
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Zinctral Zinc Oxide STARCH, CORN ALUMINUM STARCH OCTENYLSUCCINATE LEVOMENOL KUKUI NUT OIL ALOE VERA LEAF CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES MALTODEXTRIN NIACINAMIDE PETROLATUM PHENOXYETHANOL PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE HYALURONATE SODIUM GINGER ZINC OXIDE ZINC OXIDE .ALPHA.-TOCOPHEROL ACETATE, DL- SAFFLOWER OIL
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.Zinctral™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Label
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 childern. If swallowed, get medical help or contact a Poison Control Center right away.
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 condition worsens symptoms last more than 7 days or clear up and occur again within a few days
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 do not get into eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information protect from freezing avoid excessive heat Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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 When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of childern. If 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