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

Biotic-Plus by

Drug Labeling and Warnings

Biotic-Plus by is a Otc medication manufactured, distributed, or labeled by Provision Medical, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-2400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

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

Labeler - Provision Medical (036936831)

Registrant - Safetec of America, Inc. (874965262)

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