Bactine®

Bactine®
SPL v9
SPL
SPL Set ID 28e8a311-20a4-45a1-8d5d-ca42b101c275
Route
TOPICAL
Published
Effective Date 2021-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Edetate Disodium Nonoxynol-9 Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-22

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

  • cuts
  • scrapes
  • minor burns
  • sunburn
  • minor skin irritations
Section 42229-5

Drug Facts

Section 50565-1

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

Section 55105-1
Active ingredients Purpose
 Benzalkonium Cl 0.13% w/w  First aid antiseptic
 Lidocaine HCl 4% w/w  Pain relieving spray
Warnings

For external use only

Directions
  • 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
Questions?

1-844-241-5454  Mon-Fri (8-5 EST) or www.bactine.com



Drug Facts Label
Other Information

avoid excessive heat

Inactive Ingredients

edetate disodium, fragrances, propylene glycol, purified water

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
Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel 118 Ml Bottle Label

First Aid Pain Reliever & Antiseptic



Kills 99% of Germs*



Max Strength Germ Killing



4% Lidocaine HCL



Max Strength Pain Reliever



No Sting



 4 FL OZ (118 mL)

Rear Label

Principal Display Panel 148 Ml Bottle Label

First Aid Pain Reliever & Antiseptic



Kills 99% of Germs*



Max Strength Germ Killing



4% Lidocaine HCL



Max Strength Pain Reliever



No Sting



 5 FL OZ (148 mL)


Structured Label Content

Uses

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

  • cuts
  • scrapes
  • minor burns
  • sunburn
  • minor skin irritations
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
 Benzalkonium Cl 0.13% w/w  First aid antiseptic
 Lidocaine HCl 4% w/w  Pain relieving spray
Warnings

For external use only

Directions
  • 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
Questions?

1-844-241-5454  Mon-Fri (8-5 EST) or www.bactine.com



Drug Facts Label (DRUG FACTS LABEL)
Other Information (Other information)

avoid excessive heat

Inactive Ingredients (Inactive ingredients)

edetate disodium, fragrances, propylene glycol, purified water

When Using This Product (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 (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
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

First Aid Pain Reliever & Antiseptic



Kills 99% of Germs*



Max Strength Germ Killing



4% Lidocaine HCL



Max Strength Pain Reliever



No Sting



 4 FL OZ (118 mL)

Rear Label

Principal Display Panel 148 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label)

First Aid Pain Reliever & Antiseptic



Kills 99% of Germs*



Max Strength Germ Killing



4% Lidocaine HCL



Max Strength Pain Reliever



No Sting



 5 FL OZ (148 mL)


Advanced Ingredient Data


Raw Label Data

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