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Petroleum - Prescription Drug Labeling

Product NDC Code 0220-3969
Drug Name

Petroleum

Type Brand
Active Ingredients
Kerosene 5 [hp_c]/5[hp_c]
Route ORAL
Dosage Form PELLET
Labeler Name Boiron
Packages
Package NDC Code Description
0220-3969-41 5 [hp_c] in 1 tube (0220-3969-41)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Petroleum 5C (**contains 0.443 mg of the active ingredient per pellet)

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.
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
lactose, sucrose

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.
Chapped Or Cracked Fingertips*

Spl product data elements

Usually a list of ingredients in a drug product.
Petroleum KEROSENE KEROSENE KEROSENE LACTOSE, UNSPECIFIED FORM ANHYDROUS LACTOSE SUCROSE

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

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.
Do not use if pellet dispenser seal is broken. Contains approx 80 pellets. How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

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

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com [email protected] Distributed by Boiron, Inc. Newtown Square, PA 19073

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 symptoms persist for more than 3 days or worsen

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding ask a health professional before use

Disclaimer: Do not rely on openFDA 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

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