WELLY POLKA FIRST AID KIT- hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

Welly Polka First Aid Kit by

Drug Labeling and Warnings

Welly Polka First Aid Kit by is a Otc medication manufactured, distributed, or labeled by Dongguan Shenglian Tins Products Co., Ltd., Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

Warnings

For external use only.

Do not use

● in the eyes ● for treatment of diaper rash, consult a doctor.

Stop use, ask a doctor

● if condition worsens, or if symptoms persist for more than 7 days or clears up and occurs again within a few days ● with use of any other hydrocortisone product

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 of age and older: Apply to affected area not more than 3 to 4 times daily. ● Children under 2 years of age: Do not use and ask a doctor.

Other Information

● Store at 20° to 25°C (68° to 77°F).
● Do not use open or torn packets.

Inactive Ingredients

Ceteareth-20, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Mineral Oil, Petrolatum, Phenoxyethanol, Water

Questions or comments?

Call 1-833-BE-WELLY (1-833-239-3559)

Drug Facts

Active Ingredients (each gram contains)

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 5,000 units

Purposes

First aid antibiotic

Uses

First aid to help prevent infection in 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 or serious burns.

Stop use and ask a doctor if

● Condition persists or gets worse. ● You need to use longer than 1 week. ● A 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

● Clean affected area and dry thoroughly. ● Apply small amount of product (amount equal to the surface area of the tip of a finger) on the area not more than 1-3 times daily ● May be covered by sterile bandage. ● Children under 2 years of age: Do not use, consult a doctor.

Other information

● Store at 20° to 25°C (68° to 77°F).
● Do not use open or torn packets.

Inactive ingredients

Light Mineral Oil, White Petrolatum

Questions or comments?

Call 1-833-BE-WELLY (1-833-239-3559)

Package Labeling:Kit

Package Labeling:84956-011

Package Labeling:84956-007

INGREDIENTS AND APPEARANCE

WELLY POLKA FIRST AID KIT 
hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84956-009

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84956-009-01	1 in 1 KIT	07/07/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 PACKET	1.8 g
Part 2	3 PACKET	1.5 g

Part 1 of 2

HYDROCORTISONE 
hydrocortisone cream

Product Information
Item Code (Source)	NDC: 84956-011(NDC:43473-049)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84956-011-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/03/2025

Part 2 of 2

WELLY TRIPLE ANTIBIOTIC FIRST AID 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Item Code (Source)	NDC: 84956-007(NDC:69571-888)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [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	5000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84956-007-01	0.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/07/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/07/2025

Labeler - Dongguan Shenglian Tins Products Co., Ltd. (527921279)

Registrant - Dongguan Shenglian Tins Products Co., Ltd. (527921279)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(84956-011)

Establishment
Name	Address	ID/FEI	Business Operations
Dongguan Shenglian Tins Products Co., Ltd.		527921279	repack(84956-007, 84956-011) , pack(84956-009)