Bactine® 

Bactine® 
SPL v3
SPL
SPL Set ID 71300df9-6113-4f25-93ca-28ad7e7f79de
Route
TOPICAL
Published
Effective Date 2023-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (0.04 g) Polymyxin B (500 U)
Inactive Ingredients
Petrolatum Olea Europaea Fruit Volatile Oil Gossypium Herbaceum Seed Resin Sodium Pyruvate Tocopherol Cocoa Butter

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-15

Description

Lidocaine (40 mg) Bacitracin Zinc (500 units) Polymyxin B Sulfate (10,000 units)

Purpose

External analgesic First aid antibiotic First aid antibiotic


Medication Information

Purpose

External analgesic First aid antibiotic First aid antibiotic

Description

Lidocaine (40 mg) Bacitracin Zinc (500 units) Polymyxin B Sulfate (10,000 units)

Uses

First aid to help prevent infection in and temporarily relieves pain due to

  • minor cuts
  • scrapes
  • burns
Warnings

For external use only

Purpose 

External analgesic

First aid antibiotic

First aid antibiotic

Directions

Adults and children 2 years and older:

  • clean affected area
  • apply a small amount (equal to the surface area of tip of finger) on area 1 to 3 times daily.
  • may be covered with a sterile bandage.

Children under 2 years: ask a doctor

Do Not Use
  • in or near the eyes
  • on large areas of the body
Questions?

Call 1-844-241-5454 or visit Bactine.com

Allergy Alert
  • do not use If you are allergic to any of the ingredients
Distributed By:

Distributed by: WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

©2023 WellSpring Pharmaceutical Corporation

MONEY BACK GUARANTEE

Bactine Max is FSA/HSA Eligible

Other Information

Store at controlled room temperature 68º-77ºF (20º-25ºC).

Inactive Ingredients

Gossypium Herbaceum (Cotton) Seed Oil, Olea Europaea (Olive) Fruit Oil, Petrolatum, Sodium Pyruvate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

When Using This Product
  • do not use longer than 1 week unless directed by a doctor
Active Ingredients (w/w)

Lidocaine (40 mg)

Bacitracin Zinc (500 units)

Polymyxin B Sulfate (10,000 units)

Stop Use and Ask A Doctor If
  • condition lasts or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a rash or other allergic reaction occurs
Keep Out of Reach of Children
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label. Principal Display Panel

NDC #: 65197-827-05

NEW

#1 PAIN RELIEVER*

#1 ANTIBIOTIC MEDICINE**

ANTIBIOTIC + MAX PAIN RELIEF with LIDOCAINE

Kills Bacteria

Prevents Infection

Max Pain Relief

NET WT 0.5 oz (14.2 g)

NO STING - OINTMENT

*Chosen by people that believe it is the most effective pain reliever active ingredient in WellSpring proprietary consumer research

**Chosen by people that believe it is the most effective antibiotic active ingredient in WellSpring proprietary consumer research

CT82100A - Bactine Max Antibiotic

Structured Label Content

Uses

First aid to help prevent infection in and temporarily relieves pain due to

  • minor cuts
  • scrapes
  • burns
Warnings

For external use only

Purpose 

External analgesic

First aid antibiotic

First aid antibiotic

Directions

Adults and children 2 years and older:

  • clean affected area
  • apply a small amount (equal to the surface area of tip of finger) on area 1 to 3 times daily.
  • may be covered with a sterile bandage.

Children under 2 years: ask a doctor

Do Not Use (Do not use)
  • in or near the eyes
  • on large areas of the body
Questions?

Call 1-844-241-5454 or visit Bactine.com

Allergy Alert (Allergy alert)
  • do not use If you are allergic to any of the ingredients
Distributed By: (Distributed by:)

Distributed by: WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

©2023 WellSpring Pharmaceutical Corporation

MONEY BACK GUARANTEE

Bactine Max is FSA/HSA Eligible

Other Information (Other information)

Store at controlled room temperature 68º-77ºF (20º-25ºC).

Inactive Ingredients (Inactive ingredients)

Gossypium Herbaceum (Cotton) Seed Oil, Olea Europaea (Olive) Fruit Oil, Petrolatum, Sodium Pyruvate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

When Using This Product (When using this product)
  • do not use longer than 1 week unless directed by a doctor
Active Ingredients (w/w)

Lidocaine (40 mg)

Bacitracin Zinc (500 units)

Polymyxin B Sulfate (10,000 units)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition lasts or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a rash or other allergic reaction occurs
Keep Out of Reach of Children (Keep out of reach of children)
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label. Principal Display Panel (PACKAGE LABEL. PRINCIPAL DISPLAY PANEL)

NDC #: 65197-827-05

NEW

#1 PAIN RELIEVER*

#1 ANTIBIOTIC MEDICINE**

ANTIBIOTIC + MAX PAIN RELIEF with LIDOCAINE

Kills Bacteria

Prevents Infection

Max Pain Relief

NET WT 0.5 oz (14.2 g)

NO STING - OINTMENT

*Chosen by people that believe it is the most effective pain reliever active ingredient in WellSpring proprietary consumer research

**Chosen by people that believe it is the most effective antibiotic active ingredient in WellSpring proprietary consumer research

CT82100A - Bactine Max Antibiotic

Advanced Ingredient Data


Raw Label Data

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