First Aid Bacitraycin Plus Original Ointment

First Aid Bacitraycin Plus Original Ointment
SPL v3
SPL
SPL Set ID b7aefd05-c4bf-1788-e053-2995a90aa72f
Route
TOPICAL
Published
Effective Date 2018-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U])
Inactive Ingredients
Aloe Vera Leaf Light Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-04-03

Description

Active ingredient (each gram contains)                                                                         Bacitracin             500 units


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

First Aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Dosage and 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
Description

Active ingredient (each gram contains)                                                                         Bacitracin             500 units

Section 42229-5

Distributed by:

First Aid Research.

Jupiter, FL 33478

Made in India

Section 44425-7

Other information

  • store at 15° to 25° C (59° to 77° F)
  • Lot No. & Exp. Date: see box or see crimp of tube
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Section 50569-3

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

Section 50570-1

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
Section 51727-6

Inactive ingredients

aloe vera gel,  light mineral oil, and petrolatum

Section 51945-4

Section 55105-1

Purpose

First Aid Antibiotic

Section 55106-9

Active ingredient (each gram contains)                                                                        

Bacitracin             500 units


Structured Label Content

Indications and Usage (34067-9)

Uses

First Aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Distributed by:

First Aid Research.

Jupiter, FL 33478

Made in India

Section 44425-7 (44425-7)

Other information

  • store at 15° to 25° C (59° to 77° F)
  • Lot No. & Exp. Date: see box or see crimp of tube
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients

aloe vera gel,  light mineral oil, and petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

First Aid Antibiotic

Section 55106-9 (55106-9)

Active ingredient (each gram contains)                                                                        

Bacitracin             500 units


Advanced Ingredient Data


Raw Label Data

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