FDA.reportPublic FDA data

Bacitraycin MAX Pain Relief

Manufacturer
RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:44:01

Label at a glance#

ProductBacitraycin MAX Pain Relief
Active ingredientBACITRACIN ZINC, PRAMOXINE HYDROCHLORIDE
Label structure15 sections

Storage and handling

Other information store at room temperature 20° to 25° C (68° to 77° F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (each gram contains)

Bacitracin zinc 500 units

Pramoxine HCl 10mg

OTC - PURPOSE SECTION

Purpose

First Aid Antibiotic

External Analgesic

INDICATIONS & USAGE SECTION

Uses

first aid to help prevent infection and for the temporary relief of pain in minor

  • cuts
  • scrapes
  • burns

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

OTC - ASK DOCTOR SECTION

Ask a doctor before useif you have

  • deep or puncture wounds
  • animal bites
  • serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • the condition persists or gets worse
  • redness, irritation, swelling, or pain persists or increases
  • a rash or other allergic reaction develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 2 years of age and orlder:
  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • children under 2 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe vera gel and petrolatum

SPL UNCLASSIFIED SECTION

Distributed by:

CrossingWell consumer health

Box440, Cornwall, NY 12518

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMATOLOGIST

PREFERRED INGREDIENT

First Aid Antibiotic

with soothing aloe

  • Prevents Infection
  • Minimizes Scarring
  • Sting Free

Helps to

heal burns,

cuts &

scrapes

BACITRAYCIN PLUS®

Bacitracin Zinc 500 Units (First Aid Antibiotic)

Pramoxine HCl 10mg (External Analgesic)

MAX

Pain Relief

OINTMENT

NET WT. 1 OZ. (28g)

carton imagecarton image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BACITRAYCIN PLUS®

Bacitracin Zinc 500 Units (First Aid Antibiotic)

Pramoxine HCl 10mg (External Analgesic)

MAX

Pain Relief

OINTMENT

Helps to

heal burns,

cuts &

scrapes

First Aid Antibiotic

with soothing aloe

Prevents Infection
Minimizes Scarring
Sting Free

NET WT. 1 OZ. (28g)

carton imagecarton image

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-725BACITRAYCIN MAX PAIN RELIEF (BACITRACIN ZINC PRAMOXINE HCL) OINTMENT [RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH]3Legacy NDC20250101_db747126-77d2-2e1d-e053-2a95a90a2d30.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52412-72552412-725-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
PETROLATUM4T6H12BN9UIACT
BACITRACIN ZINC89Y4M234ESACTIM
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2a931cb5-4090-1886-e063-6294a90a2274db747126-77d2-2e1d-e053-2a95a90a2d302024-12-31WarningsExact identifier
spl id: 2a931cb5-4090-1886-e063-6294a90a2274
spl set id: db747126-77d2-2e1d-e053-2a95a90a2d30

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.