Bare 40 by SSG Ventures Inc BARE 40- urea gel

Bare 40 by

Drug Labeling and Warnings

Bare 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

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

INGREDIENTS AND APPEARANCE

BARE 40 
urea gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81376-221
Route of Administration	TOPICAL

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

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

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: 81376-221-01	113 g in 1 JAR; Type 0: Not a Combination Product	01/01/2021
2	NDC: 81376-221-02	113 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/01/2021
3	NDC: 81376-221-03	226 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/01/2021

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	Business Operations
SSG Ventures Inc		047626115	manufacture(81376-221)