BACITRAYCIN MAX PAIN RELIEF- bacitracin zinc pramoxine hcl ointment

Bacitraycin MAX Pain Relief by

Drug Labeling and Warnings

Bacitraycin MAX Pain Relief by is a Otc medication manufactured, distributed, or labeled by Randob Labs Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (each gram contains)

Bacitracin zinc 500 units

Pramoxine HCl 10mg

PURPOSE

Purpose

First Aid Antibiotic

External Analgesic

INDICATIONS & USAGE

Uses

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

• cuts
• scrapes
• burns

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

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

ASK DOCTOR

Ask a doctor before useif you have

• deep or puncture wounds
• animal bites
• serious burns

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

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

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

aloe vera gel and petrolatum

SPL UNCLASSIFIED SECTION

Distributed by:

CrossingWell consumer health

Box440, Cornwall, NY 12518

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)

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)

INGREDIENTS AND APPEARANCE

BACITRAYCIN MAX PAIN RELIEF 
bacitracin zinc pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52412-725
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-725-01	1 in 1 CARTON	03/30/2022
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	03/30/2022

Labeler - RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH (061995007)