Urea 40 Plus SA: Package Insert and Label Information

UREA 40 PLUS SA- urea and salicylic acid gel
SSG Ventures Inc

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.

Label
(click image for full-size original)

ACTIVE INGREDIENTS:

UREA 40%, SALICYLIC ACID 2%, TEA TREE OIL, ALOE VERA

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.

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

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.

UREA 40 PLUS SA
urea gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81376-212
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 40 g in 113 g
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6.5 g in 113 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CARBOXYPOLYMETHYLENE
XANTHAN GUM
MINERAL OIL
COCONUT OIL
WATER
TRIDECETH-10
TEA TREE OIL
PROPYLENE GLYCOL
Product Characteristics
Color white (Opaque White) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81376-212-01 113 g in 1 JAR None
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 Operations
SSG Ventures Inc 047626115 manufacture (81376-212)

Revised: 02/2021 SSG Ventures Inc

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