Petrolatum Jelly

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Petrolatum Jelly Recall

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Side Effects & Adverse Reactions

For external use only.

Condition worsens
symptoms last more than 7 days or clear up and occur in a few days.

Deep or puncture wounds
animal bites
serious burns

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Skin Protectant

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Petrolatum Jelly Manufacturers

Choice Laboratories Limited

Petrolatum Jelly | Choice Laboratories Limited

Change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply as needed

No Recall
Sion Biotext Medical Ltd

Petrolatum Jelly | Mylan Pharmaceuticals Inc.

2.1 Asthma
Montelukast sodium oral granules should be taken once daily in the evening. The following doses are recommended:

For pediatric patients 2 to 5 years of age: one packet of 4 mg oral granules.

For pediatric patients 12 to 23 months of age: one packet of 4 mg oral granules.

Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast sodium oral granules are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast sodium oral granules were administered in the evening without regard to time of food ingestion.
2.3 Allergic Rhinitis
For allergic rhinitis, montelukast sodium oral granules should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast sodium oral granules were administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.

The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:

For pediatric patients 2 to 5 years of age: one packet of 4 mg oral granules.

Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.

The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:

For pediatric patients 2 to 5 years of age: one packet of 4 mg oral granules.

For pediatric patients 6 to 23 months of age: one packet of 4 mg oral granules.

Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
2.4 Asthma and Allergic Rhinitis
Patients with both asthma and allergic rhinitis should take only one montelukast sodium oral granules dose daily in the evening.
2.5 Instructions for Administration of Oral Granules
Montelukast sodium 4 mg oral granules can be administered either directly in the mouth, dissolved in one teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature soft foods; based on stability studies, only applesauce, carrots, rice, or ice cream should be used. The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food) must be administered within 15 minutes. If mixed with baby formula, breast milk, or food, montelukast sodium oral granules must not be stored for future use. Discard any unused portion. Montelukast sodium oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration. Montelukast sodium oral granules can be administered without regard to the time of meals.

No Recall
Dynarex Corporation

Petrolatum Jelly | Dynarex Corporation

Change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply as needed

No Recall
Dynarex Corporation

Petrolatum Jelly | Dynarex Corporation

Change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply as needed

No Recall
Jell Pharmaceuticals Pvt. Ltd.

Petrolatum Jelly | Jell Pharmaceuticals Pvt. Ltd.

Change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply as needed

No Recall