Label: UREMOL 20% CREAM- urea cream
- NDC Code(s): 61344-455-25, 61344-455-50
- Packager: Odan Laboratories 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 November 20, 2023
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- Active ingredient
- Inactive ingredients
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- Dosage and Administration
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Warning
Don't use if allergic to urea or any other ingredients in Uremol. Avoid contact with eyes and mucous membrane; in case of contact, wash with water. After application, if you may notice rash, itchiness, irritation, pain, reddening, burning or discoloration of the skin, consult a healthcare practitioner. If too much is applied, irritation may occur. If irritation worsens or persists, discontinue temporarily. Consult a health care professional: if you are pregnant or breastfeeding, if symtoms worsen or last for more than 7 days or if using other topical product on your skin or for use beyond 1 month.
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INGREDIENTS AND APPEARANCE
UREMOL 20% CREAM
urea creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61344-455 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 200 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T) CAPRYLIC ACID (UNII: OBL58JN025) TRICAPRIN (UNII: O1PB8EU98M) CETEARETH-12 (UNII: 7V4MR24V5P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CARBOMER 940 (UNII: 4Q93RCW27E) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) OCTYLDODECANOL (UNII: 461N1O614Y) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61344-455-25 100 g in 1 TUBE; Type 6: Drug/Biologic Combination 05/31/2019 2 NDC:61344-455-50 225 g in 1 TUBE; Type 6: Drug/Biologic Combination 05/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/31/2019 Labeler - Odan Laboratories Ltd (208585604) Establishment Name Address ID/FEI Business Operations Odan Laboratories LTD 208585604 manufacture(61344-455)
