Active Ingredients (W/W)
Lidocaine (40 mg)
Bacitracin Zinc (500 units)
Polymyxin B Sulfate (10,000 units)
Bactine Max Antibiotic And Lidocaine Max Pain Relief Ointment
FDA Label NDC 65197-827
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Bactine Max Antibiotic And Lidocaine Max Pain Relief (NDC 65197-827). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (w/w), purpose, uses, warnings, allergy alert, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
First aid antibiotic
First aid antibiotic
Uses
First aid to help prevent infection in and temporarily relieves pain due to
- minor cuts
- scrapes
- burns
Warnings
For external use only
Allergy Alert
- do not use If you are allergic to any of the ingredients
Do Not Use
- in or near the eyes
- on large areas of the body
Ask A Doctor Before Use If You Have
- deep or puncture wounds
- animal bites
- serious burns
When Using This Product
- do not use longer than 1 week unless directed by a doctor
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.
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 68°-77°F (20°-25°C).
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
Distributed By:
Distributed by: WellSpring Pharmaceutical Corporation
Sarasota, FL 34243
©2023 WellSpring Pharmaceutical Corporation
MONEY BACK GUARANTEE
Bactine Max is FSA/HSA Eligible
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
Carton Artwork Bactine Max Antibiotic (Bactine Max Antibiotic And Lidocaine Max Pain Rel 1)
* Please review the disclaimer below.
