Label: IMU- lactobacillus helveticus, rice bran aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 71125-010-01, 71125-010-02 - Packager: RAPHAGEN CO. LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated January 12, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IMU
lactobacillus helveticus, rice bran aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71125-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTOBACILLUS HELVETICUS (UNII: Q08Z44662J) (LACTOBACILLUS HELVETICUS - UNII:Q08Z44662J) LACTOBACILLUS HELVETICUS 1.50 g in 150 mL RICE BRAN (UNII: R60QEP13IC) (RICE BRAN - UNII:R60QEP13IC) RICE BRAN 1.50 g in 150 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71125-010-02 1 in 1 CARTON 12/01/2016 1 NDC:71125-010-01 150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 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 Business Operations RAPHAGEN CO. LTD 689852157 manufacture(71125-010)
