Welly Polka First Aid Kit
FDA Label NDC 84956-009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dongguan Shenglian Tins Products Co., Ltd. for the product Welly Polka First Aid Kit (NDC 84956-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, do not use, stop use, ask a doctor, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Stop Use, Ask A Doctor

→ Keep Out Of The Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Active Ingredients (each Gram Contains)

→ Purposes

→ Ask A Doctor Before Use If You Have

→ Stop Use And Ask A Doctor If

→ Package Labeling:kit

→ Package Labeling:84956-011

→ Package Labeling:84956-007

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.

First aid to help prevent infection in minor: ● Cuts ● Scrapes ● Burns

Warnings

For external use only.

Do Not Use

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

● In the eyes ● Over large areas of the body ● If you are allergic to any of the ingredients

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.

● 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.