LONAZEM

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: LONAZEM
Generic name: MENTHOL,PETROLATUM
Manufacturer: PEER PHARM LTD.
Product type: HUMAN OTC DRUG
SPL set ID: 91f7a741-4178-4639-9cd5-746a4b9a21bf
SPL ID: 482ff6a4-8944-5564-e063-6294a90a6ff1
Version: 2
Effective date: 2026-01-12
Source export date: 2026-10-27
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:58:50

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M015	openfda.application_number
brand name		LONAZEM	openfda.brand_name
generic name		MENTHOL,PETROLATUM	openfda.generic_name
manufacturer name		PEER PHARM LTD.	openfda.manufacturer_name
ndc	package	69435-1200-1	openfda.package_ndc
ndc	product	69435-1200	openfda.product_ndc
ndc11	package	69435120001	derived:openfda.package_ndc
rxcui		2675775	openfda.rxcui
spl id		482ff6a4-8944-5564-e063-6294a90a6ff1	id
spl set id		91f7a741-4178-4639-9cd5-746a4b9a21bf	set_id
unii		4T6H12BN9U	openfda.unii
unii		L7T10EIP3A	openfda.unii

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 external and/or intrarectal use only When using this product if condition worsens or does not improve within 7 days, consult a doctor do not exceed the recommended daily dosage unless directed by a doctor in case of bleeding, consult a doctor promptly Do not insert the applicator into the rectum if it causes additional pain. Consult a doctor promptly. If Pregnant or Breastfeeding , ask a healthcare provider before using. Keep out of reach of childre n. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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