Welly First Aid Kit Refill

Welly First Aid Kit Refill
SPL v1
SPL
SPL Set ID 4bc93855-4009-4b49-9fb4-e5864054153d
Route
TOPICAL
Published
Effective Date 2025-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg) Bacitracin (2 g) Neomycin (400 [USP'U]) Polymyxin B (3.5 mg)
Inactive Ingredients
Ceteareth-20 Cetostearyl Alcohol Ethylhexylglycerin Glycerin Glyceryl Monostearate Mineral Oil Petrolatum Phenoxyethanol Water Aloe Barbadensis Leaf Juice Aminomethyl Propanol Carbomer Homopolymer, Unspecified Type Maltodextrin Menthol Polyethylene Glycol, Unspecified .alpha.-tocopherol Acetate White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-05

Description

Hydrocortisone 1%

Purpose

First aid antibiotic


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

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.

Purposes

First aid antibiotic

Warnings

For external use only.

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.

Do Not Use

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

Drug Facts

Active Ingredient

Hydrocortisone 1%

Other Information

● Store at 20° to 25°C (68° to 77°F).

● Do not use open or torn packets.

Other Information

● Store at 20° to 25°C (68° to 77°F).

● Do not use open or torn packets.

Package Labeling:

Inactive Ingredients

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

Inactive Ingredients

Mineral Oil, White Petrolatum

Questions Or Comments?

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

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

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
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.

Package Labeling:84956 007 01

Package Labeling:84956 011 01

Package Labeling:84956 017 01

Keep Out of the Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites or serious burns.

Active Ingredients (each Gram Contains)

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 5,000 units


Structured Label Content

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.

Purpose

Anti-itch

Purposes

First aid antibiotic

Warnings

For external use only.

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.

Do Not Use (Do not use)

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

Drug Facts

Active Ingredient

Hydrocortisone 1%

Other Information

● Store at 20° to 25°C (68° to 77°F).

● Do not use open or torn packets.

Other Information (Other information)

● Store at 20° to 25°C (68° to 77°F).

● Do not use open or torn packets.

Package Labeling:

Inactive Ingredients

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

Inactive Ingredients (Inactive ingredients)

Mineral Oil, White Petrolatum

Questions Or Comments? (Questions or comments?)

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

Stop Use, Ask 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

Stop Use, Ask A Doctor If (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
Stop Use and Ask A Doctor If (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.

Package Labeling:84956 007 01 (Package Labeling:84956-007-01)

Package Labeling:84956 011 01 (Package Labeling:84956-011-01)

Package Labeling:84956 017 01 (Package Labeling:84956-017-01)

Keep Out of the Reach of Children. (Keep out of the reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites or serious burns.

Active Ingredients (each Gram Contains) (Active Ingredients (each gram contains))

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 5,000 units


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)