BACITRACIN- bacitracin zinc cream

BACITRACIN by

Drug Labeling and Warnings

BACITRACIN by is a Otc medication manufactured, distributed, or labeled by HART Health, WaterJel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram):

Bacitracin zinc 500 units

PURPOSE

Purpose:

Topical Antibiotic

INDICATIONS & USAGE

Uses: First aid to help prevent infection in

• minor cuts
• scrapes
• burns
• abrasions

WARNINGS

Warnings: For external use only

• do not get in eyes
• serious burns require immediate attention

Allergy alert: do not use if you are allergic to any of the ingredients

DO NOT USE

Do not use:

• in or near the eyes
• over large portions of the body
• more than 1 to 3 times daily
• longer than 7 days unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

STOP USE

Stop use and ask a doctor if

• condition worsens or lasts for more than 7 days
• a rash or other allergic reaction occurs

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions: do not use more than directed

Adults and children 12 years of age and over:

• clean the affected area
• apply 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
• may be covered with a sterile bandage

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACITRACIN 
bacitracin zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 U  in 0.9 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0030-4	144 in 1 BOX, UNIT-DOSE	01/05/2021
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	01/05/2021

Labeler - HART Health (069560969)

Registrant - HART Health (069560969)

Establishment
Name	Address	ID/FEI	Business Operations
WaterJel Technologies		155522589	manufacture(50332-0030)