Label: BARE 40 SA- urea gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71718-003-01, 71718-003-02 - Packager: Scientific Solutions Global, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 17, 2018
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- 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
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INGREDIENTS AND APPEARANCE
BARE 40 SA
urea gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71718-003 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) SALICYLIC ACID (UNII: O414PZ4LPZ) 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:71718-003-01 113 g in 1 JAR; Type 0: Not a Combination Product 08/01/2017 2 NDC:71718-003-02 2 in 1 PACKAGE 08/01/2017 2 113 g in 1 JAR; Type 0: Not a Combination Product 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(71718-003)