OMNISPORIN- bacitracin zinc, neomycin sulfate, polymixin b gel
DR MARC'S MANUFACTURING AND SALES

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 Zinc   400 units
Neomycin Sulfate   3.5 mg
Polymyxin B   5000 units

PURPOSE

FIRST AID ANTIBIOTIC

USES

FIRST AID TO HELP TREAT, PROTECT, AND PREVENT SKIN INFECTIONS AS ASSOCIATED WITH

MINOR CUTS
SCRAPES
BURNS

WARNINGS

FOR EXTERNAL USE ONLY

Ask a doctor before use if you have

puncture wounds
deep or infected cuts
serious burn

WHEN USING THIS PRODUCT

DO NOT USE NEAR EYES OR IF YOU HAVE ANY ALLERGIES TO ANY OF THE INGREDIENTS IN THIS PRODUCT.

STOP USE AND ASK A DOCTOR IF

CONDITION WORSENS
SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR REOCCUR AFTER USE.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

Adults and children 2 years of age or older:
clean the affected area
apply a small amount on to the area once daily
cover with sterile bandage.
Children under 2 years of age: check with your doctor first.

OTHER INFORMATION

AVOID EXCESSIVE HEAT

INACTIVE INGREDIENTS

Petrolatum, Benzalkonium Chloride, Polyhexanide, Distilled Water

QUESTIONS OR COMMENTS?

818-763-9330

Omnisporin_15g_label

Omnisporin_30g_label

OMNISPORIN
bacitracin zinc, neomycin sulfate, polymixin b gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70414-108
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
POLIHEXANIDE (UNII: 322U039GMF)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70414-108-15	15 g in 1 TUBE; Type 0: Not a Combination Product	09/08/2017	04/17/2018
2	NDC:70414-108-30	30 g in 1 TUBE; Type 0: Not a Combination Product	09/08/2017	04/17/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	09/08/2017	04/17/2018

Labeler - DR MARC'S MANUFACTURING AND SALES (084006446)

Revised: 4/2018

Document Id: 2441aa47-ee3b-4c94-8d29-c7d60e017c2b

Set id: 6d78e416-91a4-4f29-b1d7-b128844c0916

Version: 2

Effective Time: 20180417

DR MARC'S MANUFACTURING AND SALES