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Jell with vitamin a d - Medication Information

Product NDC Code 30400-215
Drug Name

Jell with vitamin a d

Type Brand
Active Ingredients
Lanolin 15.5 g/100g
Petrolatum 53.4 g/100g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 664981
Application Number part347
Labeler Name Jell Pharmaceuticals Pvt Ltd.
Packages
Package NDC Code Description
30400-215-10 1 tube in 1 box (30400-215-10) / 28.3 g in 1 tube (30400-215-01)
30400-215-20 1 tube in 1 box (30400-215-20) / 56.6 g in 1 tube (30400-215-02)
30400-215-30 1 tube in 1 box (30400-215-30) / 85 g in 1 tube (30400-215-03)
30400-215-40 1 tube in 1 box (30400-215-40) / 113.3 g in 1 tube (30400-215-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Lanolin 15.5% Petrolatum 53.4%

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 skin protectant use: ■ apply as needed ■ for diaper rash: ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment 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 cod liver oil (contains vitamin A and vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

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 ■ temporarily protects minor cuts, scrapes and burns ■ temporarily protects and relieve chapped,chafed or cracked skin or lips■ protects chafed skin due to diaper rash and helps seal out wetness

Purpose

Information about the drug product’s indications for use.
Purpose Diaper rash ointment Skin protectant

Spl product data elements

Usually a list of ingredients in a drug product.
Jell with Vitamin A D Lanolin, Petrolatum PARAFFIN MICROCRYSTALLINE WAX COD LIVER OIL LIGHT MINERAL OIL PETROLATUM PETROLATUM LANOLIN LANOLIN

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.
Package Label Label

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.
Other information ■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening

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 or puncture 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

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

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

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