Urea 40 by SSG Ventures Inc UREA 40- urea gel

Urea 40 by

Drug Labeling and Warnings

Urea 40 by is a Otc medication manufactured, distributed, or labeled by SSG Ventures Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENTS:

UREA 40%

SOOTHES ROUGH & DRY SKIN

HEALS CORNS & CALLOUSES

SOOTHES ROUGH & DRY SKIN

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.

KEEP OUT OF REACH OF CHILDREN.

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

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

ENHANCED WITH TEA TREE OIL & ALOE VERA

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

INGREDIENTS AND APPEARANCE

UREA 40 
urea gel

Product 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)