BACITRAYCIN PLUS- bacitracin zinc and pramoxine hydrochloride ointment

bacitraycin plus by

Drug Labeling and Warnings

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 (in each gram) Purposes

Bacitracin zinc 500 units............First aid antibiotic

Parmoxine HCl 10 mg...............External analgesic

PURPOSE

Uses

• first aid to help prevent infection and for the temporary relief of pain in minor:
• cuts
• scrapes
• burns

WARNINGS

For external use only

DO NOT USE

Do no use

• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body or bandage

ASK DOCTOR

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

STOP USE

Stop use and ask a doctor if

• you need to use longer than 1 week
• symptoms persist for more than 1 week, or clear up and occur again within a few days
• condition persists or gets worse
• redness, irritation, swelling, or pain persists or increases
• rash or other allergic reactin develops

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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

• adults and children 2 years of age and older:
• 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
• children under 2 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients aloe vera oil, petrolatum

DOSAGE & ADMINISTRATION

Dirtributed by:

FIRST AID RESEARCH CORP.

Jupiter, FL 33478 Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACITRAYCIN PLUS 
bacitracin zinc and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75983-056
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75983-056-01	1 in 1 BOX	01/09/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 75983-056-02	1 in 1 BOX	01/09/2019
2		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	01/09/2019

Labeler - First Aid Research Corp (089405927)