Otc - Active Ingredient
fermented vinegar base 93.2%
Hongdongsam Dongan-be Soap
FDA Label NDC 84954-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyosungwon for the product Hongdongsam Dongan-be (NDC 84954-0002). 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 otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
white vinegar 4%, jojoba oil 1%, acacia scent 0.8%, sulfur hot spring water concentrate 1%
Otc - Purpose
acne, seborrheic dermatitis
Otc - Keep Out Of Reach Of Children
keep out of reach of the children
Indications & Usage
Make a lot of foam, wash it, and rinse with warm water after 2-3 minutes
Warnings
For external use only
When using this product
■ if following abnormal symptoms persist, discontinue use
Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes
■ Stop immediately and consult a doctor if you experience
1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
2) Skin Irritation
3) Following Instructions when using medication
(1) For external use only (Do not use internally)
(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)
■ Be careful not to inhale or use excessively for a long
Dosage & Administration
for topical use
Package Label.Principal Display Panel
Label (Label)
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