Label: SHA-LEM- palmitic acid, stearic acid, oleic acid, bismuth subcarbonate, boric acid ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 59862-100-11 - Packager: Shalem Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 15, 2015
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Warnings
- DOSAGE & ADMINISTRATION
- Inactive ingredient
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
SHA-LEM
palmitic acid, stearic acid, oleic acid, bismuth subcarbonate, boric acid ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59862-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PALMITIC ACID (UNII: 2V16EO95H1) (PALMITIC ACID - UNII:2V16EO95H1) PALMITIC ACID 7.25 g in 30 mL STEARIC ACID (UNII: 4ELV7Z65AP) (STEARIC ACID - UNII:4ELV7Z65AP) STEARIC ACID 7.25 g in 30 mL OLEIC ACID (UNII: 2UMI9U37CP) (OLEIC ACID - UNII:2UMI9U37CP) OLEIC ACID 14.5 g in 30 mL BISMUTH SUBCARBONATE (UNII: M41L2IN55T) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBCARBONATE 1.89 g in 30 mL BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID 0.95 g in 30 mL Inactive Ingredients Ingredient Name Strength WHITE WAX (UNII: 7G1J5DA97F) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59862-100-11 30 mL in 1 JAR; Type 0: Not a Combination Product 05/08/1992 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/08/1992 Labeler - Shalem Products, Inc. (075613914) Establishment Name Address ID/FEI Business Operations Shalem Products, Inc. 075613914 manufacture(59862-100)
