FIRST AID BACITRAYCIN PLUS ORIGINAL- bacitracin ointment

First Aid Bacitraycin Plus Original by

Drug Labeling and Warnings

First Aid Bacitraycin Plus Original by is a Otc medication manufactured, distributed, or labeled by First Aid Research Corp., Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (each gram contains)                                                                        

Bacitracin             500 units

PURPOSE

Purpose

First Aid Antibiotic

INDICATIONS & USAGE

Uses

First Aid to help prevent infection in

• minor cuts
• scrapes
• burns

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

• in the eyes
• 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 DOCTOR

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

STOP USE

Stop use and ask a doctor if

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

• store at 15° to 25° C (59° to 77° F)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

aloe vera gel,  light mineral oil, and petrolatum

SPL UNCLASSIFIED SECTION

Distributed by:

First Aid Research.

Jupiter, FL 33478

Made in India

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID BACITRAYCIN PLUS ORIGINAL 
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75983-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75983-005-02	1 in 1 CARTON	04/03/2018
1	NDC: 75983-005-01	28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	04/03/2018

Labeler - First Aid Research Corp. (089405927)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(75983-005)