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

Purpose

External analgesic First aid antibiotic First aid antibiotic

Description

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


Medication Information

Warnings

For external use only

Uses

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

  • minor cuts
  • scrapes
  • burns
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

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

Description

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

Questions?

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

Purpose 

External analgesic

First aid antibiotic

First aid antibiotic

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

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

Warnings

For external use only

Uses

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

  • minor cuts
  • scrapes
  • burns
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

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

Questions?

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

Purpose 

External analgesic

First aid antibiotic

First aid antibiotic

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

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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