Biotic-Plus (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine) Ointment [Provision Medical] -

BIOTIC-PLUS (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [PROVISION MEDICAL]
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NDC	69103-2400-1
Set ID	0d3af5c2-e24a-4070-a059-5f7ceacb6540
Category	HUMAN OTC DRUG LABEL
Packager	Provision Medical
Generic Name
Product Class	Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic
Product Number
Application Number	PART333B

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SPL UNCLASSIFIED SECTION

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

advanced Stops Pain and Prevents Infection for Cuts and Scrapes

BIOTIC-PLUS 0.5g
Active ingredients

(in each gram)

Bacitracin zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)

Lidocaine .40 mg
Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Anesthetic
Uses

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

The Provision First Aid Line

Manufactured for Provision Medical Products Palm Desert, CA 92211
Warnings
For external use only.

Keep out of reach of children

If ingested, contact a Poison Control Center directly.
Do not use
- in eyes or over large areas of the body
- more than 1 week unless directed by a doctor
- if allergic to ingredients.
Stop use, ask a doctor
- in case of deep or puncture wounds, animal bites or serious burns
- if conditions worsen or last more than 7 days
- if rash or allergic reaction occurs
Directions
- adults & children 2 years & older: clean affected area, apply amount (equal to surface area of a tip of finger) on area 1-3 times daily. May be covered with a sterile bandage.
- children under 2: do not use, ask a doctor
Inactive ingredients

white petrolatum
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOTIC-PLUS
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I)	bacitracin	400 [iU] 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 [iU] in 1 g
lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987)	lidocaine	.40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69103-2400-1	0.5 g in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	07/24/2014

Labeler - Provision Medical (036936831)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(69103-2400)

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