Raphagen
FDA Label NDC 71125-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raphagen Co. Ltd for the product Raphagen (NDC 71125-100). 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, direction, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active ingredients: Allantoin 1.0%

Inactive Ingredient

Inactive ingredients: Zea Mays (Corn) Starch, Lactobacillus/Pichia/Saccharomycopsis/Rice Bran Extract Ferment Filtrate, Arginine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Artemisia Princeps Leaf Powder, Mentha Piperita (Peppermint) Leaf, Citric Acid

Purpose

Purpose: Skin Protectant

Warnings

Warnings: For external use only 1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist. 1) In case of having problems such as red spots, swelling, itching or irritation during using this product 2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight. 2. Do not use it on the part where you have a scar, eczema or dermatitis. 3. Topical use only 4. Keep out of reach of children

Keep Out Of Reach Of Children

Keep out of reach of children

Uses

Uses: A new type of female cleanser that does not rinse with water.

Direction

Direction:
1. After taking a shower and opening a capsule, gently apply it to the vulva. 2. You can also use it to go out and use it on your underwear or sanitary pads.

Questions

Questions:

www.raphagen.com

+ 82-2-704-1005

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