Active Ingredient
Active ingredients: ALCOHOL 62.0 w%
Poltone Hand Sanitizer
FDA Label NDC 74002-3010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dongbangcosmetics Co.,ltd for the product Poltone Hand Sanitizer (NDC 74002-3010). 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 active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients:
Water, Carbomer, Triethanolamine, Polyoxyethylene Hydrogenated Castor Oil, Lavandula Angustifolia (Lavender) Oil, Methylparaben, Butylene Glycol, Hexylene Glycol, Strawberry Extract, Sophora Extract, Mulberry Root Extract, Glycyrrhiza Extract, Grapefruit Extract, Green Tea Extract
Purpose
Purpose: SANITIZER
Warnings
Warnings:
1. Do not use on the following body parts.
Around the eyes and ears, in the oral cavity, a wide range of body parts and damaged skin (may have irritating effects)
2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms
3. Other precautions
1) For external use only (do not underwear).
2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
3) Be careful not to inhale vapor when using it extensively or for a long time (if you drink ethanol vapor in large quantities or repeatedly, irritation to the mucous membrane, headache, etc. may occur). (Only for products containing ethanol)
4) When repeated use on the same site, be careful as the skin may become rough due to degreasing.
5) When used in sealed bandages, cast bandages, packs, etc., irritation symptoms may appear.
6) Do not use this medicine for anal or vaginal poultry as it may cause irritation or chemical burns.
7) Do not use for any purpose.
4. Precautions for storage
1) Avoid shading and keep it in shading.
2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign objects.
4) Taking it out of the original container and storing it in another container may cause accidents due to misuse or deterioration in quality, so store it in the original container.
Keep Out Of Reach Of Children
Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
Uses
Uses:
Disinfection of hands and skin
Directions
Directions:
Take an appropriate amount on your hands and rub thoroughly to dry.
Other Information
Other Information:
Airtight container, storage at room temperature (1~30°C)
* Please review the disclaimer below.
