Single Antibiotic with Bacitracin: Package Insert and Label Information

SINGLE ANTIBIOTIC WITH BACITRACIN- bacitracin zinc ointment
Dealmed Medical Supplies LLC

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 bacitracin)

Purpose

First Aid Antibiotic

Uses:

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

Warnings:

For external use only.

Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center directly.

Do Not Use:

  • in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if allergic to any of the ingredients

Stop use, ask a doctor if:

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

Directions:

  • clean affected area
  • apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily
  • may cover with a sterile bandage

Inactive ingredients:

mineral oil, petrolatum

Questions or Comments?

1-800-456-7077

Principal Display Panel — 0.9g Box Label

NDC 70082-601-02

dealmed

Bacitracin Ointment

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

144 Packets

NET WT. 0.9g PER PACKET

Principal Display Panel -- 0.9g Box Label
(click image for full-size original)

Principal Display Panel — 0.9g Pouch Label

dealmed

Bacitracin Ointment

0.9g (1/32 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com

Principal Display Panel -- 0.9g Pouch Label
(click image for full-size original)
SINGLE ANTIBIOTIC WITH BACITRACIN
bacitracin zinc ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70082-601
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
bacitracin zinc (bacitracin) bacitracin zinc 400 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
petrolatum
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70082-601-02 144 POUCH in 1 BOX contains a POUCH
1 0.9 g in 1 POUCH This package is contained within the BOX (70082-601-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 03/18/2022
Labeler — Dealmed Medical Supplies LLC (068586441)
Establishment
Name Address ID/FEI Operations
Safetec of America, Inc. 874965262 MANUFACTURE (70082-601)

Revised: 03/2022 Dealmed Medical Supplies LLC

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