Pure And Gentle
Mineral Oil
Medline Industries, Lp
Human Otc Drug
NDC 53329-013Pure And Gentle also known as Mineral Oil is a human otc drug labeled by 'Medline Industries, Lp'. National Drug Code (NDC) number for Pure And Gentle is 53329-013. This drug is available in dosage form of Enema. The names of the active, medicinal ingredients in Pure And Gentle drug includes Mineral Oil - 100 g/100mL . The currest status of Pure And Gentle drug is Active.
Drug Information:
| Drug NDC: | 53329-013 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Pure And Gentle |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Mineral Oil |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medline Industries, Lp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Enema |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MINERAL OIL - 100 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RECTAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 09 Apr, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part334 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Medline Industries, LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 205121
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | T5L8T28FGP
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53329-013-11 | 1 BOTTLE in 1 BOX (53329-013-11) / 133 mL in 1 BOTTLE | 09 Apr, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose lubricant laxative
Product Elements:
Pure and gentle mineral oil mineral oil mineral oil
Indications and Usage:
Uses for relief of occasional constipation this product generally produces bowel movement in 2 to 15 minutes
Warnings:
Warnings for rectal use only caution: to be taken only at bedtime. do not use at any other time or administer to infants, except upon the advice of a physician. do not use on children under 13 years of age on pregnant women on persons with difficulty swallowing on bedridden patients if you are presently taking a stool softener laxative or take with meals ask a doctor before use if you have already used a laxative for more than 3 days have abdominal pain, nausea or vomiting have a sudden change in bowel habits that persists over a period of 2 weeks stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use as with any drug, if you are nursing a baby, seek the advice of a health professional before using this product. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222)
Do Not Use:
Warnings for rectal use only caution: to be taken only at bedtime. do not use at any other time or administer to infants, except upon the advice of a physician. do not use on children under 13 years of age on pregnant women on persons with difficulty swallowing on bedridden patients if you are presently taking a stool softener laxative or take with meals ask a doctor before use if you have already used a laxative for more than 3 days have abdominal pain, nausea or vomiting have a sudden change in bowel habits that persists over a period of 2 weeks stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use as with any drug, if you are nursing a baby, seek the advice of a health professional before using this product. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222)
Dosage and Administration:
Directions (or as directed by a doctor) rectal enema dosage is 120 ml in a single daily dosage (per 24 hours) adults & children 13 years and over 1 bottle children under 13 years of age do not use caution: remove green protective shield before inserting: hold bottle upright, grasping bottle cap with fingers. grasp protective shield with other hand and pull gently to remove positioning: left-side position: lie on left side with knee bent and arms at rest. knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface. position arms comfortably. administering enema: with steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. insertion may be easier if person receiving enema bears down, as if having a bowel movement. this helps relax the muscles around the anus. do not force the enema tip into rectum as this can cause injury. squeeze bottle until nearly all liquid is gone. it is
Read more... not necessary to empty the bottle completely, as it contains more liquid than needed. remove enema tip from rectum. this product generally produces a bowel movement in 2 to 15 minutes. do not retain enema solution in body for longer than 15 minutes. remove protective shield illustration left side position illustration knee-chest position illustration
Stop Use:
Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use
Package Label Principal Display Panel:
Package label label
Further Questions:
Questions or comments? 1-866-323-0107 m-f 8 am to 5 pm