WELLY SUPERHERO SUPPLIES KIT- alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hydrochloride, hydrocortisone kit

Welly Superhero Supplies Kit by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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 allergic reactions 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

Burn Gel

Drug Facts

Active ingredient

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns

Warnings

External use only

Do not use

• near eyes, if this happens, rinse thoroughly with water
• in large quantities, particularly over raw or blistered areas

Stop use, ask doctor

• if conditions worsen or last more than 7 days or clears up and returns.

Keep out of reach of children. If ingested contact a Poison Control Center directly

Directions

• adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
• children under 2: do not use, ask a doctor

Inactive ingredients

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, vitamin E acetate

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

SPL UNCLASSIFIED SECTION

ASSORTED FIRST AID OINTMENTS

ASSORTED SINGLE USE PACKETS

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

Recycle me!

WellyTM www.GetWelly.com

Superhero Supplies

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

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

9 - BURN GEL 0.9G (1/32 OZ)

9 - 1% HYDROCORTISONE 0.9g (1/32 OZ)

Packaging

INGREDIENTS AND APPEARANCE

WELLY SUPERHERO SUPPLIES KIT 
alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hydrochloride, hydrocortisone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72663-140

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-140-32	1 in 1 KIT; Type 0: Not a Combination Product	03/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	9 POUCH	8.1 mL
Part 2	9 POUCH	4.5 mL
Part 3	9 POUCH	8.1 mL
Part 4	9 POUCH	8.1 mL

Part 1 of 4

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

Part 2 of 4

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 3 of 4

ANALGESIC 
lidocaine hydrochloride gel

Product Information
Item Code (Source)	NDC: 72663-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)

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 4 of 4

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2019

Labeler - Welly Health PBC (116766884)