Rugby Bacitracin Zinc Ointment

SPL v4

SPL

SPL Set ID ac3c9897-c812-1360-e053-2a95a90ad591

Route

TOPICAL

Published

Effective Date 2023-07-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [USP'U])

Inactive Ingredients

Mineral Oil Petrolatum Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-04-15

Description

Bacitracin Zinc 500 Units per gram

Purpose

First Aid Antibiotic

Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 Units per gram

Uses

First Aid to help prevent infection in

minor cuts
scrapes
burns

Warnings

For External Use Only.

Packaging

Questions

Call 1-800-645-2158

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

Do Not Use

in 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

Active Ingredient

Bacitracin Zinc 500 Units per gram

Other Information

Store Between 15° to 25°C (59° to 77°F)

Lot No. and Expiration Date: See box and tube crimp

Distributed By:

RUGBY LABORATORIES

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

1-800-645-2158

Made in China

Inactive Ingredients

Aloe barbadensis leaf juice, mineral oil, petrolatum

Ask Doctor Before Use

In care of deep puncture wounds, animal bites, or serious burns.

Stop Use and Ask Doctor If

The condition persists or gets worse
A rash or allergic reaction develops

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses

First Aid to help prevent infection in

minor cuts
scrapes
burns

Purpose

First Aid Antibiotic

Warnings

For External Use Only.

Packaging

Questions

Call 1-800-645-2158

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

Do Not Use

in 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

Active Ingredient

Bacitracin Zinc 500 Units per gram

Other Information

Store Between 15° to 25°C (59° to 77°F)

Lot No. and Expiration Date: See box and tube crimp

Distributed By:

RUGBY LABORATORIES

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

1-800-645-2158

Made in China

Inactive Ingredients

Aloe barbadensis leaf juice, mineral oil, petrolatum

Ask Doctor Before Use (Ask Doctor before Use)

In care of deep puncture wounds, animal bites, or serious burns.

Stop Use and Ask Doctor If (Stop Use and Ask Doctor if)

The condition persists or gets worse
A rash or allergic reaction develops

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "First Aid to help prevent infection in minor cuts scrapes burns", "Purpose": "First Aid Antibiotic", "Warnings": "For External Use Only.", "Questions": "Call 1-800-645-2158", "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", "Do Not Use": "in 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", "Active Ingredient": "Bacitracin Zinc 500 Units per gram", "Other Information": "Store Between 15° to 25°C (59° to 77°F) Lot No. and Expiration Date: See box and tube crimp Distributed By: RUGBY LABORATORIES 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com 1-800-645-2158 Made in China", "Inactive Ingredients": "Aloe barbadensis leaf juice, mineral oil, petrolatum", "Ask Doctor before Use": "In care of deep puncture wounds, animal bites, or serious burns.", "Stop Use and Ask Doctor if": "The condition persists or gets worse A rash or allergic reaction develops", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:54.505015 · Updated: 2026-03-14T23:06:03.178139