cvs pharmacy, inc. triple antibiotic & burn relief drug facts

cvs pharmacy, inc. triple antibiotic & burn relief drug facts
SPL v4
SPL
SPL Set ID fdc510b8-f3ad-4bd6-a8d0-1b81e9f30e13
Route
topical
Published
Effective Date 2024-11-13
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
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-03-05

Purpose

First aid antibiotic External analgesic

Description

Bacitracin zinc 500 units Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg


Medication Information

Warnings

For external use only

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

External analgesic

Directions
  • adults and children 2 years of age or older:
  • 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
  • children under 2 years of age: ask a doctor
Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients

white petrolatum

Description

Bacitracin zinc 500 units Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg

Do Not Use
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Questions Or Comments?

1-800-719-9260

Stop Use and Ask A Doctor If
  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops
Keep Out of Reach of Children.

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

Active Ingredients (in Each Gram)

Bacitracin zinc 500 units

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Package/label Principal Display Panel

CVS Health®

Compare to the active ingredients in Neosporin® + Burn Relief

MAXIMUM STRENGTH± OINTMENT

Triple Antibiotic & Burn Relief

BACTIRACIN ZINC

NEOMYCIN SULFATE

POLYMYXIN B SULFATE

PRAMOXINE HCl

First aid antibiotic/pain relieving ointment

Infection protection and burn pain relief

BURN CARE

Package Contains One Tube

NET WT 0.5 OZ (14 g)

±Under OTC Monograph


Structured Label Content

Warnings

For external use only

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

External analgesic

Directions
  • adults and children 2 years of age or older:
  • 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
  • children under 2 years of age: ask a doctor
Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

white petrolatum

Do Not Use (Do not use)
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Questions Or Comments? (Questions or comments?)

1-800-719-9260

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other 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 right away (1-800-222-1222).

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin zinc 500 units

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package/label Principal Display Panel (Package/Label Principal Display Panel)

CVS Health®

Compare to the active ingredients in Neosporin® + Burn Relief

MAXIMUM STRENGTH± OINTMENT

Triple Antibiotic & Burn Relief

BACTIRACIN ZINC

NEOMYCIN SULFATE

POLYMYXIN B SULFATE

PRAMOXINE HCl

First aid antibiotic/pain relieving ointment

Infection protection and burn pain relief

BURN CARE

Package Contains One Tube

NET WT 0.5 OZ (14 g)

±Under OTC Monograph


Advanced Ingredient Data


Raw Label Data

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