POLVO DE SULFA POWDER - CCP as CMO (42523-115)

POLVO DE SULFA FIRST AID ANTIBIOTIC by

Drug Labeling and Warnings

POLVO DE SULFA FIRST AID ANTIBIOTIC by is a Otc medication manufactured, distributed, or labeled by Coastal Contract Packaging, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

POLVO DE SULFA FIRST AID ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate powder 
Coastal Contract Packaging, Inc.

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POLVO DE SULFA POWDER - CCP as CMO (42523-115)

Active Ingredients:

BACITRACIN ZINC 500 UNITS

POLYMYXIN B SULFATE 10,000 UNITS

Purpose:

First aid antibiotic

Uses

First aid to help prevent infection in minor

• cuts
• scrapes
• burns

Warnings

• For external use only

Do not use

• in the eyes
• if you are allergic to any of the ingredients
• over large areas of the body
• longer than 1 week unless directed by doctor

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

• the conditions persists or gets worse
• a rash or other allergic reaction develops

Keep out of reach of childern.If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older:

• clean the affected area
• apply a light dusting of the powder on the area 1 to 3 times daily
• may be covered with a sterile bandage

Children under 2 years of age: consult a doctor

Inactive Ingredient

Lactose

POLVO DE SULFA FIRST AID ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42523-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [USP'U]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42523-115-75	1 in 1 BOX	05/26/2025
1		7.5 g in 1 BOTTLE; 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	05/26/2025

Labeler - Coastal Contract Packaging, Inc. (137341611)

Revised: 6/2025

Document Id: 37b88f6e-726a-eb56-e063-6294a90a072d

34390-5

Set id: 37b88f6e-7269-eb56-e063-6294a90a072d

Version: 1

Effective Time: 20250616