MedPath

iShanCare

Approved
Approval ID

3617ca21-7543-6d2e-e063-6394a90aea89

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Mar 1, 2025

Manufacturers
FDA

Shenzhen Ishan Technology Co., Ltd

DUNS: 554484192

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

First Aid Burn Ointment

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73076-178
Product Classification
G
Generic Name
First Aid Burn Ointment
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2025
FDA Product Classification

INGREDIENTS (10)

CAMELLIA OILActive
Quantity: 0.3 g in 100 g
Code: T1PE06G0VE
Classification: ACTIB
PSEUDOLARIX AMABILIS BARKInactive
Code: 49G13A93VE
Classification: IACT
SOPHORA FLAVESCENS ROOTInactive
Code: IYR6K8KQ5K
Classification: IACT
RHEUM PALMATUM ROOTInactive
Code: G025DAL7CE
Classification: IACT
SANGUISORBA OFFICINALIS ROOTInactive
Code: 4NYV2HT01X
Classification: IACT
SMILAX GLABRA TUBERInactive
Code: PES3YXA3LR
Classification: IACT
ZINC OXIDEInactive
Code: SOI2LOH54Z
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PHELLODENDRINEInactive
Code: AR68S526RB
Classification: IACT
STEMONA JAPONICA WHOLEInactive
Code: 9633V7NM0W
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2025

Lable

Burn ointment

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2025

Directions

For adults and children 2 years ofage or older. Clean the affected area.Apply a small amount of the ointment to the affected area, not more than3 to 4 times daily. For children under 2 years ofage, ask a doctor before use.

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 1/1/2025

Ask a doctor if

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2025

Active ingredient

Camellia Oil 0.3%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2025

Inactive ingredient

Pseudolarix Amabilis Bark, Sophora Flavescens Root Extract, RheumPalmatum Root, Sanguisorba Officinalis , Smilax Glabra Rhizome, Calamina,Phellodendri Chinensis Cortex, Stemona Japonica Whole.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2025

Keep out of reach of children.

if swallowed, call poison control or seek medical help.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 1/1/2025

Stop use and ask a doctor if

pain worsens or persists, or if youexperience any of these symptoms: burning, itching, rash, or other changes in theskin where the product was placed.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2025

USES

First aid to help prevent bacterial contamination or skin infection, and fortemporary relief of pain and itching associated with minor burns, scaldssunburns, cuts, and scrapes.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/1/2025

Other information

Store in a cool, dry place.
This is not a toy and should be kept out of reach of young children.

Discard the product if the packaging has been opened. Do not use.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2025

Dosage & administration

Apply not more than 3 to 4 times

USER SAFETY WARNINGS SECTION

LOINC: 54433-8Updated: 1/1/2025

When using this product

Do not wear this product directly on skin.

Be aware of low-temperature burns.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2025

Warning

For external use only. When using this product do not get into eyes. Stopuse and ask a doctor if your condition worsens, does not improve, persistsin more than 7 days, or occurs again after a few days. Consult a doctorbefore using on animal bites or serious burns. Keep out ofreach of childrenf swallowed, call poison control or seek medical help.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 3/24/2025

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

iShanCare - FDA Drug Approval Details