Urea 20 by SSG Ventures Inc UREA 20- urea gel

Urea 20 by

Drug Labeling and Warnings

Urea 20 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

Inactive Ingredients

PRESERVED WATER, MINERAL OIL, PROPYLENE GLYCOL, TRIETHANOLAMINE, COCONUT OIL, EMULTHIX, CARBOMER, XANTHAN GUM, TEA TREE OIL, ALOE VERA, METHYLPARABEN, PROPYLPARABEN

Inactive Ingredients

CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE
GLYCOL, EMULSIFIERS, TRIETHANOLOAMINE

Directions

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

Active Ingredients

UREA 20%

DIRECTIONS:

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

Indications:

SOOTHES ROUGH & DRY SKINSOFTEN NAILSMOISTURIZING GEL

KEEP OUT OF REACH OF CHILDREN.

UREA

REDUCES CORNS & CALLUSES

SAFETY WARNING :

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 20 
urea gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81376-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
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)
TEA TREE OIL (UNII: VIF565UC2G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

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: 81376-210-08	113 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/20/2019

Labeler - SSG Ventures Inc (047626115)

Establishment
Name	Address	ID/FEI	Business Operations
SSG Ventures Inc		047626115	manufacture(81376-210)