Label: BARE 40- urea gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71718-002-01, 71718-002-02, 71718-002-03 - Packager: Scientific Solutions Global, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated March 22, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE
- INDICATIONS & USAGE
- SAFETY WARNING :
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS:
- INACTIVE INGREDIENTS :
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PACKAGING:
-
INGREDIENTS AND APPEARANCE
BARE 40
urea gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71718-002 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) 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:71718-002-01 113 g in 1 JAR; Type 0: Not a Combination Product 08/01/2017 2 NDC:71718-002-02 2 in 1 PACKAGE 08/01/2017 2 113 g in 1 JAR; Type 0: Not a Combination Product 3 NDC:71718-002-03 226 g in 1 TUBE; 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(71718-002)
