Bactine®

Bactine®
SPL v2
SPL
SPL Set ID 09b32a98-9131-451e-87a6-81a1e4ed7ec5
Route
TOPICAL
Published
Effective Date 2023-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Edetate Disodium Glycerin Sodium Hydroxide Aloe Vera Leaf Benzyl Alcohol Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

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

Description

Lidocaine HCl 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine HCl 4%

Uses

temporarily relieves minor pain 

Warnings

For external use only

Flammable
  • keep away from fire or flame
Purpose 

Topical anesthetic

Back Panel

New

Bactine Max

Liquid Bandage with Lidocaine

SHAKE WELL

Bactine Max Liquid Bandageʼs unique formula provides maximum strength pain relief with LIDOCAINE, kills 99.9% of germs*, and protects hard-to-cover minor cuts and scrapes. This flexible bandage dries clear quickly and is breathable to maximize healing.

Directions
  • adults and children 2 years of age and older:
  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • children 12 years or younger: ask a doctor
  • children under 2 years of age: do not use
Do Not Use
  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
Questions?

1-844-241-5454 or Bactine.com

Distributed By:

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

© 2023 WellSpring Pharmaceutical Corporation



Other Information

Store at room temperature

Inactive Ingredients

aloe barbadensis leaf juice, carbomer, disodium EDTA, glycerin, phenylcarbinol, purified water, sodium hydroxide.

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to area of use
Active Ingredients (w/w)

Lidocaine HCl 4%

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
If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children and Pets
  • If swallowed, get medical help or contact a Poison Control Center right away.
Package Label. Principal Display Panel

NO MESS MAX PAIN RELIEF WITH LIDOCAINE

Numbs Away Pain and Itch

Fast Acting

For Pain, Minor Burns, Bug Bites & Sunburn

Max Strength Lidocaine

No Mess Applicator

Fast Acting 

With Aloe Vera

Non-Greasy

Quick Dry Formula

HSA/FSA Eligible

MONEY BACK GUARANTEE

IMPORTANT:

Keep this carton for future reference on full labeling.

* Max Lidocaine HCL concentration per FDA External Analgesic OTC monograph

NDC 65197-840-25

Bactine Max Roll-on Artwork


Structured Label Content

Uses

temporarily relieves minor pain 

Warnings

For external use only

Flammable
  • keep away from fire or flame
Purpose 

Topical anesthetic

Back Panel

New

Bactine Max

Liquid Bandage with Lidocaine

SHAKE WELL

Bactine Max Liquid Bandageʼs unique formula provides maximum strength pain relief with LIDOCAINE, kills 99.9% of germs*, and protects hard-to-cover minor cuts and scrapes. This flexible bandage dries clear quickly and is breathable to maximize healing.

Directions
  • adults and children 2 years of age and older:
  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • children 12 years or younger: ask a doctor
  • children under 2 years of age: do not use
Do Not Use (Do not use)
  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
Questions?

1-844-241-5454 or Bactine.com

Distributed By: (Distributed by:)

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

© 2023 WellSpring Pharmaceutical Corporation



Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, carbomer, disodium EDTA, glycerin, phenylcarbinol, purified water, sodium hydroxide.

When Using This Product (When using this product)
  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to area of use
Active Ingredients (w/w)

Lidocaine HCl 4%

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
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)
  • If swallowed, get medical help or contact a Poison Control Center right away.
Package Label. Principal Display Panel (PACKAGE LABEL. PRINCIPAL DISPLAY PANEL)

NO MESS MAX PAIN RELIEF WITH LIDOCAINE

Numbs Away Pain and Itch

Fast Acting

For Pain, Minor Burns, Bug Bites & Sunburn

Max Strength Lidocaine

No Mess Applicator

Fast Acting 

With Aloe Vera

Non-Greasy

Quick Dry Formula

HSA/FSA Eligible

MONEY BACK GUARANTEE

IMPORTANT:

Keep this carton for future reference on full labeling.

* Max Lidocaine HCL concentration per FDA External Analgesic OTC monograph

NDC 65197-840-25

Bactine Max Roll-on Artwork


Advanced Ingredient Data


Raw Label Data

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