FIRST AID MAXIMUM STRENGTH BACITRAYCIN PLUS- bacitracin, and pramoxine hcl ointment

First Aid Maximum Strength Bacitraycin Plus by

Drug Labeling and Warnings

First Aid Maximum Strength Bacitraycin Plus by is a Otc medication manufactured, distributed, or labeled by First Aid Research Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (each gram contains) Purpose

Bacitracin 500 units.......................................................................................................First Aid Antibiotic

Pramoxine HCI 10 mg..................................................................................................Pain Reliever

PURPOSE

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
• if you are allergic to any of the ingredients
• over large areas of the body
• 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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

INDICATIONS & USAGE

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 leaf, methylparaben, mineral oil, petrolatum, propylparaben, stearyl alcohol

DOSAGE & ADMINISTRATION

Distributed by:

First Aid Research Corp.

Jupiter, FL 33478

Made in Korea

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID MAXIMUM STRENGTH BACITRAYCIN PLUS 
bacitracin, and pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75983-055
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
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75983-055-28	1 in 1 CARTON	03/01/2018
1		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	03/01/2018

Labeler - First Aid Research Corp (089405927)