iShanCare
3617ca21-7543-6d2e-e063-6394a90aea89
HUMAN OTC DRUG LABEL
Mar 1, 2025
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
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Lable
INDICATIONS & USAGE SECTION
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
Ask a doctor if
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Camellia Oil 0.3%
INACTIVE INGREDIENT SECTION
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
Keep out of reach of children.
if swallowed, call poison control or seek medical help.
OTC - STOP USE SECTION
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
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
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
Dosage & administration
Apply not more than 3 to 4 times
USER SAFETY WARNINGS SECTION
When using this product
Do not wear this product directly on skin.
Be aware of low-temperature burns.
WARNINGS SECTION
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.