RAPHAGEN POWDE R- allantoin powder 
RAPHAGEN CO. LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

RAPHAGEN  POWDE R
allantoin powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71125-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.007 g  in 0.7 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
Arginine (UNII: 94ZLA3W45F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71125-100-0210 in 1 CARTON10/01/2017
1NDC:71125-100-010.7 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2017
Labeler - RAPHAGEN CO. LTD (689852157)
Registrant - RAPHAGEN CO. LTD (689852157)
Establishment
NameAddressID/FEIBusiness Operations
RAPHAGEN CO. LTD689852157manufacture(71125-100)

Revised: 11/2017
Document Id: e64695bd-c0bc-43df-ae05-4f4dcaed16fc
Set id: 59411513-b260-4944-b874-fe157bdc2952
Version: 1
Effective Time: 20171120
 
RAPHAGEN CO. LTD