FDA.reportPublic FDA data

Bactine Original First Aid

Manufacturer
WellSpring Pharmaceutical Corporation
Effective date
2017-12-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 23:44:16

Label at a glance#

ProductBactine Original First Aid
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

first aid to help prevent skin infection, and for temporary relief of pain and itching associated with minor: cuts scrapes burns

Dosage and administration

adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first) children under 2 years: ask a doctor

Storage and handling

avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
 Benzalkonium Cl 0.13% w/w First aid antiseptic
 Lidocaine HCl 2.5% w/w Pain relieving liquid

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent skin infection, and for temporary relief of pain and itching associated with minor:

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days, or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first)
  • children under 2 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

edetate disodium, fragrances, nonoxynol 9, propylene glycol, purified water

Questions?

OTC - QUESTIONS SECTION

1-844-241-5454 or www.bactine.com Money Back Guarantee

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bactine®

NO STING

Original
First Aid Liquid

FIRST AID ANTISEPTIC & PAIN RELIEVER

Cleans • Soothes Instantly
Prevents Infection

4 FL OZ (120 mL)

Bactine 4 oz
Bactine 4 oz

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65197-81065197-810-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
EDETATE DISODIUM7FLD91C86KIACT
NONOXYNOL-948Q180SH9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
795aeedc-d984-47f5-8dd6-c789e645325bb9ac2951-bf10-47e7-8e9d-7d6ceda701c52017-12-13WarningsExact identifier
spl id: 795aeedc-d984-47f5-8dd6-c789e645325b
spl set id: b9ac2951-bf10-47e7-8e9d-7d6ceda701c5

Reported adverse events (FAERS/openFDA)#

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