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Product NDC Code | 68786-213 | ||||||||||||
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Drug Name | Vitamin a d |
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Type | Brand | ||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||
Dosage Form | OINTMENT | ||||||||||||
RxCUI drug identifier | 1440181 | ||||||||||||
Application Number | M016 | ||||||||||||
Labeler Name | Sion Biotext Medical Ltd. | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient White Petrolatum USP (93% w/w)
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 Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D
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 treat and prevent diaper rash Helps seal out wetness Temporarily protects minor * cuts * scrapes * burns Temporarily helps protect and help relieve chapped and cracked skin and lips Helps prevent and protect from the drying effects of wind and cold weather Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged
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.Vitamin A D WHITE PETROLATUM VITAMIN A VITAMIN D LANOLIN LIGHT MINERAL OIL PETROLATUM PETROLATUM
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 NDC 68786-213-01 Vitamins A&D Ointment Intensive Moisturizer for Skin Therapy For Personal and Professional Use SION MEDICAL Made in Israel 144 Packets Net Wt. 0.17oz(5g) NDC 68786-213-02 Vitamins A&D Ointment Intensive Moistuirzer for Skin Therapy For Personal and Professional Use SION MEDICAL Made in Israel 4 tubes Net Wt 4 oz (113 g) NDC 68786-213-03 Vitamins A&D Ointment Diaper Rash Ointment Skin Protectant Made in Israel 12 tubes Net Wt 4 oz (113 g) NDC 68786-213-04 Vitamins A&D Ointment Diaper Rash Ointment Skin Protectant Made in Israel 1 tube Net Wt 4 oz (113 g) NDC 68786-213-05 Vitamins A&D Ointment Diaper Rash Ointment Skin Protectant Made in Israel 144 Packets 0.18 oz (5 g) Label 1 Label 2 IMAGE 3 IMAGE 4 IMAGE 5
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if The condition persists or gets worse Symptoms last more than 7 days or clear up and occur again in a few days
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 Deep puncture or wounds Animal bites Serious burns
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 swallowed, get medical help or contact a Poison Control Center right away
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: Store at controlled room temperature 15 0 C to 30 0 C (59 0 - 86 0 F) Avoid excessive heat and humidity Tamper Evident. Do not use if packet is torn, cut or open.
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 The condition persists or gets worse Symptoms last more than 7 days or clear up and occur again in a few days Do not use on Deep puncture or wounds Animal bites Serious burns Keep out of reach of children 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