Randob Labs Bacitraycin Plus MAX Pain Relief 1oz

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]

BACITRAYCIN MAX PAIN RELIEF- bacitracin zinc pramoxine hcl ointment 
Randob Labs Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Randob Labs Bacitraycin Plus MAX Pain Relief 1oz

Active ingredient (each gram contains)

Bacitracin zinc 500 units

Pramoxine HCl 10mg

Purpose

First Aid Antibiotic

External Analgesic

Uses

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

• cuts
• scrapes
• burns

Warnings

For external use only.

Do not use

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

Ask a doctor before useif you have

• deep or puncture wounds
• animal bites
• serious burns

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

If pregnant or breast-feeding,

ask a health professional before use.

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

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

Other information

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

Inactive ingredients

aloe vera gel and petrolatum

Distributed by:

CrossingWell consumer health

Box440, Cornwall, NY 12518

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)

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)

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 final	part333B	03/30/2022

Labeler - Randob Labs Ltd. (061995007)

Revised: 3/2022

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

34390-5

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

Version: 1

Effective Time: 20220330