Refill 3

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: Refill 3
Generic name: BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Manufacturer: CMC Group Inc.
Product type: HUMAN OTC DRUG
SPL set ID: e5cb395f-5037-4b0e-9c9d-2d78b5b01b25
SPL ID: 2b9cfd46-fb22-a682-e063-6394a90a6ba3
Version: 8
Effective date: 2025-01-13
Source export date: 2026-10-27
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/a758d73d4d838a965005e6adf01b928e2da86f99be0f8bbaeeb95f3b7acbe418/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:57:13

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		M003	openfda.application_number
brand name		Refill 3	openfda.brand_name
generic name		BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		CMC Group Inc.	openfda.manufacturer_name
ndc	package	49687-0017-0	openfda.package_ndc
ndc	product	49687-0017	openfda.product_ndc
ndc11	package	49687001700	derived:openfda.package_ndc
rxcui		1012100	openfda.rxcui
spl id		2b9cfd46-fb22-a682-e063-6394a90a6ba3	id
spl set id		e5cb395f-5037-4b0e-9c9d-2d78b5b01b25	set_id
unii		F5UM2KM3W7	openfda.unii
unii		V13007Z41A	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 use only. Do not use • in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns. Stop use and ask a doctor if • the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reah of children. 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.