Quality Choice Triple Antibiotic Ointment Plus Pain Relief

Quality Choice Triple Antibiotic Ointment Plus Pain Relief
SPL v3
SPL
SPL Set ID a7d5e12e-c6bf-44b0-e053-2995a90a1ce2
Route
TOPICAL
Published
Effective Date 2020-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U]) Neomycin (3.5 mg) Polymyxin B (10000 [USP'U]) Pramoxine (10 mg)
Inactive Ingredients
Light Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-06-15

Description

Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic


Medication Information

Warnings and Precautions

Warnings For external use only.

Do not use ● in the eyes ● over large areas of the body

● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds ● animal bites ● serious burns.

Stop use and ask a doctor if condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops

Indications and Usage

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Purpose

First aid antibiotic

Description

Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units

Section 50565-1

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

Section 51727-6

Inactive ingredient Mineral Oil,Petrolatum

Packaging

Directions

● clean the affected area and dry thoroughly.

● 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.

Active Ingredient

Pramoxine HCL

Other Information

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

questions: 800-935-2362

Product of PRC

Other Information

● To open: unscrew cap, pull tab to remove foil seal







● store at 20° to 25°C ( 68° to 77°F)

● see carton or tube crimp for lot number and expiration date.

Active Ingredients (each Gram Contains)

Bacitracin zinc 400 units







Neomycin sulfate 3.5 mg







Polymyxin B sulfate 5,000 units


Structured Label Content

Indications and Usage (34067-9)

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Warnings and Precautions (34071-1)

Warnings For external use only.

Do not use ● in the eyes ● over large areas of the body

● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds ● animal bites ● serious burns.

Stop use and ask a doctor if condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops

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 51727-6 (51727-6)

Inactive ingredient Mineral Oil,Petrolatum

Purpose

First aid antibiotic

Packaging

Directions

● clean the affected area and dry thoroughly.

● 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.

Active Ingredient

Pramoxine HCL

Other Information

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

questions: 800-935-2362

Product of PRC

Other Information (Other information)

● To open: unscrew cap, pull tab to remove foil seal







● store at 20° to 25°C ( 68° to 77°F)

● see carton or tube crimp for lot number and expiration date.

Active Ingredients (each Gram Contains) (Active ingredients (each gram contains))

Bacitracin zinc 400 units







Neomycin sulfate 3.5 mg







Polymyxin B sulfate 5,000 units


Advanced Ingredient Data


Raw Label Data

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