Drug Details [pdf]

PARAID TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Mcure Health Solutions Inc

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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Bacitracin Zinc 400 units

Neomycin Sulfate (3.5mg Neomycin)

Polymyxin B Sulfate 5000 units

Purpose

First Aid Antibiotics

Uses: First aid to help prevent infection in minor cuts, scrapes and burns.

For external use only.

Do not use internally in eyes over large areas of the body or on puncture wounds, animal bites or serious burns for more than 1 week unless directed by a doctor if you have allergies to any of the ingredients.

Stop use and ask a doctor if

a rash or allergic reaction develops
condition worsens or persists

Keep out of reach of children

If ingested, contact a Poison Control Center immediately.

Inactive ingredients

Purified water

TRIETHANOLAMINE ACRYLATES/BEHENETH - 25 METHACRYLATE COPOLYMER

Directions

Clean affected area
Apply a small amount 1 to 3 times daily
May cover with a sterile bandage

TRIPLE ANTIBIOTIC OINTMENT

0.9g

(1/32 oz.)

338f2e5d-cf66-5fac-e054-00144ff8d46c

PARAID TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52486-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 U in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 U in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BEHENETH-25 METHACRYLATE (UNII: 108R05PWG6)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52486-007-09	0.9 g in 1 PACKET; Type 0: Not a Combination Product	05/24/2016	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	05/24/2016	01/31/2019

Labeler - Mcure Health Solutions Inc (053034873)

Revised: 10/2019

Document Id: 96039de2-fafa-5228-e053-2a95a90a74e3

Set id: 338f2e5d-cf66-5fac-e054-00144ff8d46c

Version: 2

Effective Time: 20191028

Drug Labeling and Warnings

Drug Details [pdf]