WELLY HUMAN REPAIR KIT- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, hydrocortisone, alcohol kit

Welly Human Repair Kit by

Drug Labeling and Warnings

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

Drug Details [pdf]

Triple Antibiotic Ointment

Drug Facts

Active ingredient (in each gram)

Bacitracin zinc 400 units

Neomycin sulfate (3.5mg Neomycin)

Polymyxin B sulfate 5000 units

Purpose

First Aid Antibiotics

Uses

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

Warnings

For external use only

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

Stop use and ask a doctor if

• a rash or other allergic reaction develops
• condition worsens or persists

Keep out of reach of children. If ingested, contact a Poison Control Center right away.

Directions

• clean affected area
• apply a small amount 1 to 3 times daily
• may cover with a sterile bandage

Inactive Ingredients

petrolatum

1% Hydrocortisone Cream

Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

• For temporary relief of itching associated with minor skin irritations, inflammation, or rashes.
• Other uses of product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Do not use

• in eyes
• for treatment of diaper rash
• for feminine itching

Stop use, ask a doctor

• if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
• with use of other hydrocortisone products

Keep out of reach of children. If ingested, contact a Poison Control Center right away

Directions

• apply to affected area not more than 3 to 4 times daily
• children under 2: ask a doctor

Inactive ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Instant Hand Sanitizer Gel

Drug Facts

Active ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on skin without soap and water.

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use in eyes, if this happens, rinse thoroughly with water.

Stop use, ask a doctor if, irritation develops and persists for 72 hours.

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

Directions

• Wet hands & wrists thoroughly with product and allow to dry without wiping

Inactive ingredients

aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

SPL UNCLASSIFIED SECTION

FIRST AID TRAVEL KIT

ASSORTED BANDAGES & OINTMENTS

First aid kit sized for travel with everything you'll need and nothing you won't.

• Flexible fabric bandages in two sizes and a few colors to cover cuts and scratches.
• Hand Sanitizer helps keep hands clean when there's no sink in sight.
• Triple Antibiotic ointment helps prevent infection.
• 1% Hydrocortisone anti-itch ointment helps relieve skin irritation and rashes.

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

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

Recycle me!

WellyTM www.GetWelly.com

Human Repair Kit

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

15 BANDAGES - 5/8 X 2 1/4 IN (1.6 X 5.7 CM)

3 - TRIPLE ANTIBIOTIC 0.5g (1/57 OZ)

3 - 1% HYDROCORTISONE 0.9g (1/32 OZ)

6 - HAND SANITIZER 0.9g (1/32 OZ)

Packaging

INGREDIENTS AND APPEARANCE

WELLY HUMAN REPAIR KIT 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, hydrocortisone, alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72663-130

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-130-23	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	03/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	3 POUCH	1.5 mL
Part 2	3 POUCH	2.7 mL
Part 3	6 POUCH	5.4 mL

Part 1 of 3

ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Item Code (Source)	NDC: 72663-560
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	6.0 mg  in 1 mL
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 mL
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	0.77 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5 mL in 1 POUCH; 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	02/25/2019

Part 2 of 3

ANTI-ITCH 
hydrocortisone cream

Product Information
Item Code (Source)	NDC: 72663-580
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.9 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/25/2019

Part 3 of 3

ANTISEPTIC 
alcohol gel

Product Information
Item Code (Source)	NDC: 72663-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	666 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.9 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2019

Labeler - Welly Health PBC (116766884)