Bactine Max

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: Bactine Max
Generic name: BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE
Manufacturer: WellSpring Pharmaceutical Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 28e8a311-20a4-45a1-8d5d-ca42b101c275
SPL ID: ec2ae48c-3497-4a66-a88c-4838a37ad3df
Version: 9
Effective date: 2021-02-24
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:43:26

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M003	openfda.application_number
brand name		Bactine Max	openfda.brand_name
generic name		BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		WellSpring Pharmaceutical Corporation	openfda.manufacturer_name
ndc	package	65197-811-15	openfda.package_ndc
ndc	package	65197-811-14	openfda.package_ndc
ndc	product	65197-811	openfda.product_ndc
ndc11	package	65197081115	derived:openfda.package_ndc
ndc11	package	65197081114	derived:openfda.package_ndc
rxcui		2047879	openfda.rxcui
rxcui		2047877	openfda.rxcui
spl id		ec2ae48c-3497-4a66-a88c-4838a37ad3df	id
spl set id		28e8a311-20a4-45a1-8d5d-ca42b101c275	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 Ask a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use in or near the eyes do not apply over large areas of the body or in large quantities do not apply over raw surfaces or blistered areas Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days, or clear up and occur again within a few days Keep out of reach 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.