UREA 40 PLUS HA- urea gel

Urea 40 Plus HA by

Drug Labeling and Warnings

Urea 40 Plus HA by is a Otc medication manufactured, distributed, or labeled by Scientific Solutions Global LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENTS:

UREA

SOOTHES ROUGH & DRY SKIN

HEALS CORNS & CALLOUSES

SOFTENS NAILS

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.

ALOE VERA, CARBOMER, COCONUT OIL, EMULSIFIERS, GREEN TEA, MINERAL OIL, PRESERVED WATER, POPYLENE GLYCOL, SODIUM HYALURONATE, TEA TREE OIL, TRIETHANOLOAMINE, XANTHAM GUM

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 PLUS HA 
urea gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71718-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	40 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
MINERAL OIL (UNII: T5L8T28FGP)
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
TRIDECETH-10 (UNII: G624N6MSBA)
TEA TREE OIL (UNII: VIF565UC2G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

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: 71718-213-01	113 g in 1 JAR; Type 0: Not a Combination Product	09/20/2019
2	NDC: 71718-213-02	113 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/20/2019
3	NDC: 71718-213-03	226 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/26/2019

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

Labeler - Scientific Solutions Global LLC (097291290)

Establishment
Name	Address	ID/FEI	Business Operations
Scientific Solutions Global LLC		097291290	manufacture(71718-213)