OTC Medication Information: BACITRACIN ZINC

BACITRACIN ZINC- bacitracin zinc ointment
GERI-CARE PHARMACEUTICAL CORP

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.

Active ingredient (in each gram)

Bacitracin Zinc 500 units

Purpose

First Aid Antibiotic

Uses

First aid to help prevent infection in
• minor cuts • scrapes • burns

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 a doctor

Ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns.

Stop use and ask a doctor if

• condition persists or gets worse
• rash or other allergic reaction develops

Keep out of the reach of children. If swallowed, get
medical help or contact a Poison Control Center right away.

Directions

• 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

Other information

• Tamper Evident. Do not use if packet is torn, cut or opened.
• Store at room temperature 15° to 30°C (59° to 86°F)
• Avoid excessive heat and humidity

Inactive Ingredients

mineral oil and white petrolatum

Questions and comments

1-800-540-3765

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BACITRACIN ZINC
bacitracin zinc ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57896-111-14 144 PACKAGE in 1 CARTON contains a PACKAGE (57896-111-09)
1 NDC:57896-111-09 0.9 g in 1 PACKAGE This package is contained within the CARTON (57896-111-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 05/01/2020
Labeler — GERI-CARE PHARMACEUTICAL CORP (611196254)
Registrant — GERI-CARE PHARMACEUTICAL CORP (611196254)

Revised: 05/2020 GERI-CARE PHARMACEUTICAL CORP

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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