SPL v7
SPL
SPL Set ID 9446375d-4bb4-4bb1-bdc2-c18e995bfe26
Route
TOPICAL
Published
Effective Date 2019-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (6 mg) Neomycin (3.5 mg) Polymyxin B (0.77 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-25

Description

Drug Facts

Purpose

First Aid Antibiotics


Medication Information

Purpose

First Aid

Antibiotics

Description

Drug Facts

Uses

First aid to help prevent infection in minor cuts, scrapes, and burns

Section 42229-5

Drug Facts

Warnings

External use only.

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
Do Not Use
  • internally
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Active Ingredient

(in each gram)

Bacitracin zinc 400 units

Neomycin sulfate (3.5 mg Neomycin) Polymyxin B sulfate 5000 units

Inactive Ingredients

petrolatum

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Stop Use, Ask A Doctor
  • a rash or allergic reactions develops
  • condition worsens or persists
Keep Out of Reach of Children.

If ingested, contact a Poison Control Center right away.

Principal Display Panel Antibiotic Pouch Label

Welly™

Triple Antibiotic

Ointment

0.5g/ 1/57 OZ


Structured Label Content

Uses

First aid to help prevent infection in minor cuts, scrapes, and burns

Section 42229-5 (42229-5)

Drug Facts

Purpose

First Aid

Antibiotics

Warnings

External use only.

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
Do Not Use (Do not use)
  • internally
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Active Ingredient (Active ingredient)

(in each gram)

Bacitracin zinc 400 units

Neomycin sulfate (3.5 mg Neomycin) Polymyxin B sulfate 5000 units

Inactive Ingredients (Inactive ingredients)

petrolatum

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Stop Use, Ask A Doctor (Stop use, ask a doctor)
  • a rash or allergic reactions develops
  • condition worsens or persists
Keep Out of Reach of Children. (Keep out of reach of children.)

If ingested, contact a Poison Control Center right away.

Principal Display Panel Antibiotic Pouch Label (Principal Display Panel - Antibiotic Pouch Label)

Welly™

Triple Antibiotic

Ointment

0.5g/ 1/57 OZ


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)