Family Care Bacitracin Zinc Ointment 0.33 Oz 496a Zdp

SPL v3

SPL

SPL Set ID df27620e-7312-8082-e053-2995a90aaca6

Route

TOPICAL

Published

Effective Date 2022-05-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [USP'U])

Inactive Ingredients

Methylparaben Stearyl Alcohol Light Mineral Oil Alcohol Petrolatum Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-05-17

Description

Active ingredient (in each gram) Purpose Bacitracin Zinc 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 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: United Exchange Corp.

Cypress, CA 90630 USA

Made in China

Description

Active ingredient (in each gram) Purpose Bacitracin Zinc 500 units..............................................First aid antibiotic

Section 44425-7

Other information

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

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

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

Section 50569-3

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Section 50570-1

Do not use

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

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 (in each gram) Purpose

Bacitracin Zinc 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 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: United Exchange Corp.

Cypress, CA 90630 USA

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

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

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

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Section 50570-1 (50570-1)

Do not use

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

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 (in each gram) Purpose

Bacitracin Zinc 500 units..............................................First aid antibiotic

Advanced Ingredient Data

[{"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions clean the affected area apply a small amount of this product (an amount 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", "34068-7": "Distributed by: United Exchange Corp. Cypress, CA 90630 USA Made in China", "34071-1": "Warnings For external use only", "44425-7": "Other information store at room temperature 20-25°C (68-77°F)", "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.", "50566-9": "Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops", "50569-3": "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns", "50570-1": "Do not use if you are allergic to any of the ingredients in the eyes over large areas of the body", "51727-6": "Inactive ingredients aloe vera leaf extract, ethyl alcohol, light mineral oil, methylparaben, petrolatum stearyl alcohol", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Uses first aid to help prevent infection in minor: cuts scrapes burns", "55106-9": "Active ingredient (in each gram) Purpose Bacitracin Zinc 500 units..............................................First aid antibiotic"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.288482 · Updated: 2026-03-14T23:13:13.649161