Pure and Gentle

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Pure and Gentle
Generic name
MINERAL OIL
Manufacturer
Medline Industries, LP
Product type
HUMAN OTC DRUG
SPL set ID
96d4cad5-0602-4c31-94ed-3117b4fd4a94
SPL ID
27d437bf-4b2b-eb33-e063-6394a90a4ef6
Version
8
Effective date
2024-11-26
Source export date
2026-10-27
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/6f51a1483736359ffd78ed7be27289bc51f2a8463b934465bee40efbdef4dfd7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 21:06:42
Harmonized routes table
Harmonized routes
RECTAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

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)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.