Active Ingredient
Active ingredients: ALCOHOL 70.0 w%
Pure Perfect Sanitizer
FDA Label NDC 74716-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Buddy Co., Ltd. for the product Pure Perfect Sanitizer (NDC 74716-010). 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, PEG-60 Hydrogenated Castor Oil, Sodium Hyaluronate, Camellia Sinesis Leaf Extract, Morus Alba Bark Extract, Aloe Barbadensis, Leaf Extract, Olea Europaea(Olive) Fruit Oil, Tocopheryl Acetate
Purpose
Purpose: Antiseptic
Warnings
Warnings:
1. Do not use the product on the following areas :
Around the eyes and ears, in the mouth, large body part and damaged skin(it may cause irritation.)
2. If you suffer from the next symptom, discontinue use of the product immediately and consult a physician or pharmacist.
1) Hypersensitivity symptoms e.g. rash, erythema, itchiness, and edema
2) Skin irritation symptoms
3. Other precautions
1) For external use only. (Do not swllow.)
2) Avoid contact with eyes. If it contacts with eyes, wash with clean clean water and consult a physician or a pharmacist.
3) Be careful not to inhale vapors in case of using for a long time.
(In case of inhaling large amounts of ethanol vapor, it may cause irritation of the mucous membranes and headaches.)
(Limited to ethanol-containing the product)
4) If you use this product on the same area repeatedly, cure should be provided as the skin may become rough due to excessive oil removal.
5) Do not use sealed bandages, cast bandages, or packs as they many cause irritation.
6) Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns.
7) Use only for the intended purpose.
4. Precaution for storage
1) Keep away from direct sunlight and do not expose the product to heating devices or flame.
2) Let the children not touch this drug and in case of swallowing it, go to the hospital immediately.
3) After use. close the lid completely and prevent the product from drying or foreign objects from getting inside the container.
4) In case of keeping the product on the different container, it may cause accidents or deterioration of quality.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Uses
Uses:
Disinfection of hands and skin
Directions
Directions:
Spray an appropriate amount on your hands and rub thoroughly to dry.
Other Information
Other information
■ Read directions and precautions before use.
■ Avoid freezing and excessive heat above 40℃.
* Please review the disclaimer below.
