Label: UREA 40- urea gel
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Contains inactivated NDC Code(s)
NDC Code(s): 81376-211-01, 81376-211-03 - Packager: SSG Ventures Inc
- 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 April 7, 2021
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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.
KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.
KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.
APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.
PRESERVED WATER, MINERAL OIL, PROPYLENE GLYCOL, TRIETHANOLAMINE, COCONUT OIL, EMULTHIX, CARBOMER, XANTHAM GUM, TEA TREE OIL, ALOE VERA, METHYLPARABEN, PROPYLPARABEN
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INGREDIENTS AND APPEARANCE
UREA 40
urea gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81376-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 4 g in 10 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) XANTHAN GUM (UNII: TTV12P4NEE) MINERAL OIL (UNII: T5L8T28FGP) COCONUT OIL (UNII: Q9L0O73W7L) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) TEA TREE OIL (UNII: VIF565UC2G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white (Opaque White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81376-211-01 113 mL in 1 JAR; Type 0: Not a Combination Product 04/01/2021 2 NDC:81376-211-03 226 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2021 Labeler - SSG Ventures Inc (047626115) Establishment Name Address ID/FEI Business Operations SSG Ventures Inc 047626115 manufacture(81376-211)