IMU- lactobacillus helveticus, rice bran aerosol, foam 
RAPHAGEN CO. LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredient: LACTOBACILLUS HELVETICUS 1.00 % , RICE BRAN 1.00%

INACTIVE INGREDIENT

Inactive Ingredients: Water(Aqua), Glycerin, Cocamidopropyl Betaine, Decyl Glucoside, Alcohol, Propanediol, Paeonia Suffruticosa Root Extract, Allantoin, Centella Asiatica Extract, Sodium Chloride, Hydroxyacetophenone, PEG-60 Hydrogenated Castor Oil, Lactic Acid, Menthol, Disodium EDTA, Fragrance(Parfum)

PURPOSE

Purpose: Sanitizer

WARNINGS

Warnings: 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

INDICATIONS & USAGE

Indications & usage: 1. Two or three times the pump out less on the palm of the press an adequate amount of foam. 2. Rub gently massage it in as along the external genitals and anal. 3. Rinse with tepid water well. 4. You can use every day. 1 day more than three times.

DOSAGE & ADMINISTRATION

Dosage & Administration: Two or three times the pump out less on the palm of the press an adequate amount of foam.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

IMU 
lactobacillus helveticus, rice bran aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71125-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LACTOBACILLUS HELVETICUS (UNII: Q08Z44662J) (LACTOBACILLUS HELVETICUS - UNII:Q08Z44662J) LACTOBACILLUS HELVETICUS1.50 g  in 150 mL
RICE BRAN (UNII: R60QEP13IC) (RICE BRAN - UNII:R60QEP13IC) RICE BRAN1.50 g  in 150 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71125-010-021 in 1 CARTON12/01/2016
1NDC:71125-010-01150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2016
Labeler - RAPHAGEN CO. LTD (689852157)
Registrant - RAPHAGEN CO. LTD (689852157)
Establishment
NameAddressID/FEIBusiness Operations
RAPHAGEN CO. LTD689852157manufacture(71125-010)

Revised: 1/2017
Document Id: fe6b6c5f-0d9e-46f2-ac18-a676e2da96db
Set id: 568a9b73-d4e8-4596-8aa3-123382a6e4c9
Version: 1
Effective Time: 20170112
 
RAPHAGEN CO. LTD