TheraCare Bacitracin Zinc

TheraCare Bacitracin Zinc by

Drug Labeling and Warnings

TheraCare Bacitracin Zinc by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THERACARE BACITRACIN ZINC- first aid antibiotic ointment 
Veridian Healthcare

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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TheraCare Bacitracin Zinc

Active Ingredient

Bacitracin Zinc (500 units in each gram)

Purpose

First Aid Antibiotic

Uses

first aid to help prevent infection in minor cuts, scrapes, and 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 use if you have

deep or puncture wounds, serious burns, animal bites

Stop use and ask a doctor if

• you need to use longer than 1 week
• the condition persists or gets worse
• rash or other allergic reaction develops

Keep out of reach of children

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

When using this product

use as directed

Directions

adults or children 2 years of age and older:

• 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.
• May be covered with a sterile bandage.

children under 2 years of age:ask a doctor

Other Information

• store at room temperature 20-25C (68-78F)
• do not use if tube seal under cap is broken

Inactive Ingredients

Light mineral Oil, Hard Paraffin, Petrolatum

Questions and comments?

866-326-1313

Label

THERACARE BACITRACIN ZINC 
first aid antibiotic ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-230
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

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-230-01	1 in 1 BOX	05/01/2023
1		28.3 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	05/01/2023

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(71101-230)

Revised: 5/2023

Document Id: faf5457d-7471-7310-e053-6394a90a60d5

34390-5

Set id: faf55940-2121-ec0a-e053-6394a90afa8a

Version: 1

Effective Time: 20230505