WELLY BRAVERY FIRST AID KIT- bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hcl kit

Welly Bravery First Aid Kit by

Drug Labeling and Warnings

Welly Bravery First Aid Kit by is a Otc medication manufactured, distributed, or labeled by Welly Health PBC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc 500 Units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 Units

Pramoxine Hydrochloride 10 mg

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

Uses:

Helps prevent infection in and temporarily relieves pain due to minor: cuts scrapes burns

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 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 the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions:

Adults and children 2 years and older: clean affected area apply a small amount (equal to the surface area of tip of finger) on area 1 to 3 times daily. may be covered with a sterile bandage.
Children under 2 years: ask a doctor.

Other information:

Store at a controlled room temperature 68°-77°F (20°-25°C)

Inactive Ingredient:

Petrolatum

QUESTIONS

Questions? 1-833-BE-WELLY

SPL UNCLASSIFIED SECTION

TRIPLE ANTIBIOTIC + PAIN RELIEF & STANDARD BANDAGES 

Triple Antibiotic Ointment Plus Pain Relief First Aid Kit 

• Triple Antibiotic + Pain relief ointment to help prevent infection.
• Flexible Fabric bandages included in a few designs to cover cuts and scrapes.
• Durable tin for portability and easy storage.

Product not made with natural rubber latex.
Bandages are sterile unless individual wrapper opened.

Bravery First Aid Kit

1 TUBE- TRIPLE ANTIBIOTIC + PAIN RELIEF 0.5  OZ (14g)

12 BANDAGES - 3/4 x 3 IN (1.9 x 7.6 CM)

Distributed by: Welly Health PBC
Minneapolis, MN 55402
1-833-BE-WELLY

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WellyTM www.GetWelly.com

Packaging

INGREDIENTS AND APPEARANCE

WELLY BRAVERY FIRST AID KIT 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72663-171

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-171-05	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	08/07/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	14 g

Part 1 of 1

WELLY BRAVERY TRIPLE ANTIBIOTIC WITH PAIN RELIEF 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hcl ointment

Product Information
Item Code (Source)	NDC: 72663-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/07/2019

Labeler - Welly Health PBC (116766884)