Bare 40 HA by Scientific Solutions Global, LLC BARE 40 HA- urea gel

Bare 40 HA by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS:

UREA

PURPOSE

HEALS CORNS & CALLUSES

INDICATIONS & USAGE

SOOTHES ROUGH & DRY SKIN

SOFTEN NAILS

MOISTURIZING GEL

SAFETY WARNING:

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.

STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS:

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.

USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

INACTIVE INGREDIENTS:

TEA TREE OIL, ALOE VERA, SODIUM HYALURONATE, CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE GLYCOL, EMULSIFIERS, TRIETHANOLAMINE, COCONUT OIL, PRESERVED WATER

STORAGE AND HANDLING

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

SPL UNCLASSIFIED SECTION

ENHANCED WITH ALOE VERA & TEA TREE OIL

MAXIMUM STRENGTH

VISIT US AT: UREAEVERYTHING.COM

Packaging

INGREDIENTS AND APPEARANCE

BARE 40 HA 
urea gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71718-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	40 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
TRIDECETH-10 (UNII: G624N6MSBA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71718-004-01	113 g in 1 JAR; Type 0: Not a Combination Product	08/01/2017
2	NDC: 71718-004-02	2 in 1 PACKAGE	08/01/2017
2		113 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 71718-004-03	226 g in 1 JAR; Type 0: Not a Combination Product	03/21/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2017

Labeler - Scientific Solutions Global, LLC (097291290)

Establishment
Name	Address	ID/FEI	Business Operations
Scientific Solutions Global, LLC		097291290	manufacture(71718-004)