Label: RAPHAGEN POWDE R- allantoin powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 20, 2017

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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

  • INGREDIENTS AND APPEARANCE
    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)
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