Bacitracin: Package Insert and Label Information

BACITRACIN- bacitracin ointment
Dynarex Corporation

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

Bacitracin (500 units in each gram)

Purpose

First Aid Antibiotic

Use

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For External Use Only

Do not use

  • In the eyes or apply over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds, animal bites, or serious burns

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

Store at room temperature

Inactive ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Label

1161 BX MASTER
(click image for full-size original)

Label

1162 BX MASTER
(click image for full-size original)

Label

1163 BX MASTER
(click image for full-size original)

BACITRACIN
bacitracin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 500 [USP’U] in 1000 mg
Inactive Ingredients
Ingredient Name Strength
WHITE PETROLATUM
PARAFFIN
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67777-116-20 72 TUBE in 1 CASE contains a TUBE (67777-116-21)
1 NDC:67777-116-21 14000 mg in 1 TUBE This package is contained within the CASE (67777-116-20)
2 NDC:67777-116-10 1728 BOX in 1 CASE contains a BOX (67777-116-11)
2 NDC:67777-116-11 144 PACKET in 1 BOX This package is contained within the CASE (67777-116-10) and contains a PACKET
2 900 mg in 1 PACKET This package is contained within a BOX (67777-116-11) and a CASE (67777-116-10)
3 NDC:67777-116-30 72 BOX in 1 CASE contains a BOX (67777-116-31)
3 NDC:67777-116-31 1 TUBE in 1 BOX This package is contained within the CASE (67777-116-30) and contains a TUBE
3 28400 mg in 1 TUBE This package is contained within a BOX (67777-116-31) and a CASE (67777-116-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 09/12/2016
Labeler — Dynarex Corporation (008124539)

Revised: 11/2022 Dynarex Corporation

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