OTC Medication Information: IMU

IMU- lactobacillus helveticus and 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.

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

IMU lactobacillus helveticus, rice bran aerosol, foam

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71125-010 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTOBACILLUS HELVETICUS (LACTOBACILLUS HELVETICUS) LACTOBACILLUS HELVETICUS 1.50 g in 150 mL RICE BRAN (RICE BRAN) RICE BRAN 1.50 g in 150 mL

Inactive Ingredients Ingredient Name Strength Water Glycerin

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71125-010-02 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP (71125-010-01) 1 NDC:71125-010-01 150 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (71125-010-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/2016

Labeler — RAPHAGEN CO. LTD (689852157)

Registrant — RAPHAGEN CO. LTD (689852157)

Establishment
Name	Address	ID/FEI	Operations
RAPHAGEN CO. LTD		689852157	manufacture (71125-010)

Revised: 01/2017 RAPHAGEN CO. LTD