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NDC 52412-0725-01 Bacitraycin MAX Pain Relief 500; 10 [USP'U]/g; mg/g Details

Bacitraycin MAX Pain Relief 500; 10 [USP'U]/g; mg/g

Bacitraycin MAX Pain Relief is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Randob Labs Ltd.. The primary component is BACITRACIN ZINC; PRAMOXINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Bacitracin is used to help prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Bacitracin is in a class of medications called antibiotics. Bacitracin works by stopping the growth of bacteria.

Related Packages: 52412-0725-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bacitracin Topical

Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 52412-0725-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine

Product Information

NDC	52412-0725
Product ID	52412-725_db747368-d45f-64e3-e053-2995a90a1fb8
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Bacitraycin MAX Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc Pramoxine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500; 10
Active Ingredient Units	[USP'U]/g; mg/g
Substance Name	BACITRACIN ZINC; PRAMOXINE HYDROCHLORIDE
Labeler Name	Randob Labs Ltd.
Pharmaceutical Class	Decreased Cell Wall Synthesis & Repair [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2023-12-31

Package

Package Images

NDC 52412-0725-01 (52412072501)

Pricing Information	N/A
NDC Package Code	52412-725-01
Billing NDC	52412072501
Package	1 TUBE in 1 CARTON (52412-725-01) / 28 g in 1 TUBE
Marketing Start Date	2022-03-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL db747126-77d2-2e1d-e053-2a95a90a2d30 Details

SPL UNCLASSIFIED SECTION

Active ingredient (each gram contains)

Bacitracin zinc 500 units

Pramoxine HCl 10mg

SPL UNCLASSIFIED SECTION

Purpose

First Aid Antibiotic

External Analgesic

SPL UNCLASSIFIED SECTION

Uses

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

cuts
scrapes
burns

SPL UNCLASSIFIED SECTION

Warnings

For external use only.

SPL UNCLASSIFIED SECTION

Do not use

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

SPL UNCLASSIFIED SECTION

Ask a doctor before useif you have

deep or puncture wounds
animal bites
serious burns

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding,

ask a health professional before use.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED SECTION

Other information

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

SPL UNCLASSIFIED SECTION

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	03/30/2022

Labeler - Randob Labs Ltd. (061995007)

Revised: 3/2022

Document Id: db747368-d45f-64e3-e053-2995a90a1fb8

Set id: db747126-77d2-2e1d-e053-2a95a90a2d30

Version: 1

Effective Time: 20220330

Search by Drug Name or NDC

NDC 52412-0725-01 Bacitraycin MAX Pain Relief 500; 10 [USP'U]/g; mg/g Details

Bacitraycin MAX Pain Relief 500; 10 [USP'U]/g; mg/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 52412-0725-01 (52412072501)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL db747126-77d2-2e1d-e053-2a95a90a2d30 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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