CVS Health Bacitracin Zinc: Package Insert and Label Information

CVS HEALTH BACITRACIN ZINC- bacitracin zinc ointment
CVS Health

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.

Drug Facts

Active ingredients (In each gram)

Bacitracin USP 500 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor:

• cuts
• scrapes
• burns

Warnings

For external use only

Allergy alert:

• do not use if you are allergic to any of the ingredients

Do not use

• in or near the eyes
• on large areas of the body

Consult a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not use longer than 1 week

Stop use and consult a doctor if

• condition persists or gets worse
• symptoms last for more than 7 days or clear up and come back within a few days
• a rash or other allergic reaction develops

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

Directions

• clean the affected area
• apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
• may be covered with a sterile bandage

Other information

• Store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive ingredient

Petrolatum

Distributed by: CVS Pharmacy Inc. questions call 1-800-SHOP CVS

Principal Display Panel – Packette

CVS Health NDC 69842-163-10

Bacitracin Zinc Ointment USP Bacitracin Zinc

First Aid Antibiotic Ointment

NET WT. 0.03 oz. (0.9g)

Principal Display Panel – Carton Label

CVS Health NDC 69842-163-10

Bacitracin Zinc Ointment USP Bacitracin Zinc

First Aid Antibiotic Ointment

NET WT. 0.72 oz. (20.4g)
First Aid Treatment for Minor Cuts, Scrapes and Burns

CVS HEALTH BACITRACIN ZINC bacitracin zinc ointment

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-163 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin Zinc (Bacitracin) Bacitracin 500 [USP’U] in 1 g

Inactive Ingredients Ingredient Name Strength Petrolatum

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69842-163-10 24 PACKET in 1 CARTON contains a PACKET 1 0.9 g in 1 PACKET This package is contained within the CARTON (69842-163-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 04/28/2017

Labeler — CVS Health (062312574)

Registrant — Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE (69842-163)

Revised: 08/2017 CVS Health