Bare 40: Package Insert and Label Information

BARE 40- urea 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)

Urea 40%

SOOTHES ROUGH & DRY SKIN

WORKS ON CORNS & CALLUSES

SOFTENS NAILS

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED

SAFETY WARNING:

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. KEEP OUT OF REACH OF CHILDREN. STOP USE IF CONDITION WORSENS OR CLEARS UP AND REOCCURS

KEEP LID FIRMLY CLOSED. STORE IN A COOL DRY PLACE

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

APPLY TO AFFECTED AREA AT LEAST TQICE DAILY OR AS NEEDED

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT A DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT A DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS

BARE 40
urea gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81376-221
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 40 g in 40 g
Inactive Ingredients
Ingredient Name Strength
TRIDECETH-10
XANTHAN GUM
MINERAL OIL
CARBOXYPOLYMETHYLENE
PROPYLENE GLYCOL
ALOE VERA LEAF
COCONUT OIL
WATER
TEA TREE OIL
Product Characteristics
Color white (OPAQUE WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81376-221-01 113 g in 1 JAR None
2 NDC:81376-221-02 113 g in 1 BOTTLE, DISPENSING None
3 NDC:81376-221-03 226 g in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2021
Labeler — SSG Ventures Inc (047626115)
Establishment
Name Address ID/FEI Operations
SSG Ventures Inc 047626115 manufacture (81376-221)

Revised: 02/2021 SSG Ventures Inc

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