RAPHAGEN

Manufacturer
RAPHAGEN CO. LTD
Effective date
2017-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:01

Label at a glance#

ProductRAPHAGEN POWDE R
Active ingredientAllantoin
Label structure9 sections

Indications and uses

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Allantoin 1.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Uses

INDICATIONS & USAGE SECTION

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

Direction

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71125-100-022020-01-31C16284748780-19d75b9d1-1d9a-f424-e053-dadaa90a57ce59411513-b260-4944-b874-fe157bdc2952

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71125-100-01RAPHAGENPOWDE R0.7 g in 1 CONTAINERPOWDER0.71
71125-100-02RAPHAGENPOWDE R10 in 1 CARTONPOWDER101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71125-100RAPHAGEN POWDE R (ALLANTOIN) POWDER [RAPHAGEN CO. LTD]1Legacy NDC, 2 package rows20171120_59411513-b260-4944-b874-fe157bdc2952.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71125-10071125-100-01, 71125-100-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Allantoin344S277G0ZACTIB
STARCH, CORNO8232NY3SJIACT
Arginine94ZLA3W45FIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e64695bd-c0bc-43df-ae05-4f4dcaed16fc59411513-b260-4944-b874-fe157bdc29522017-11-20WarningsExact identifier
spl id: e64695bd-c0bc-43df-ae05-4f4dcaed16fc
spl set id: 59411513-b260-4944-b874-fe157bdc2952

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.