Zapotol Termicina Antibiotic Ointment 0.5oz 1350a Zdp

Zapotol Termicina Antibiotic Ointment 0.5oz 1350a Zdp
SPL v5
SPL
SPL Set ID c8704895-8819-49ac-8baa-5b97be1d00aa
Route
TOPICAL
Published
Effective Date 2016-10-13
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 Stearyl Alcohol Methylparaben Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-08-06

Description

Active ingredient (each gram contains)                                      Purpose Bacitracin 500 units.....................................................................First Aid Antibiotic


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and 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
Dosage and Administration

DISTRIBUTED BY:

Productos Zapotol Corp.

Palmdate, CA

Made in China

Description

Active ingredient (each gram contains)                                      Purpose Bacitracin 500 units.....................................................................First Aid Antibiotic

Section 44425-7

Other Information

  • Store at 20°C to 25°C (68°F to 77°F)
  • keep carton for future reference
  • tamper evident: do not use if carton or foil under cap is broker or missing
Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • rash or other allergic reaction develops
Section 50570-1

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
Section 51727-6

Inactive ingredients

aloe vera leaf extract, ethyl alcohol, light mineral oil, methylparaben, petrolatum, stearyl alcohol

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Section 55106-9

Active ingredient (each gram contains)                                      Purpose

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


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

DISTRIBUTED BY:

Productos Zapotol Corp.

Palmdate, CA

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other Information

  • Store at 20°C to 25°C (68°F to 77°F)
  • keep carton for future reference
  • tamper evident: do not use if carton or foil under cap is broker or missing
Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • rash or other allergic reaction develops
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
Section 51727-6 (51727-6)

Inactive ingredients

aloe vera leaf extract, ethyl alcohol, light mineral oil, methylparaben, petrolatum, stearyl alcohol

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Section 55106-9 (55106-9)

Active ingredient (each gram contains)                                      Purpose

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


Advanced Ingredient Data


Raw Label Data

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