Label: COMPOUND BENZOIN TINCTURE- tincture of benzoin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 12745-109-01, 12745-109-02, 12745-109-03, 12745-109-04 - Packager: Medical Chemical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 17, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COMPOUND BENZOIN TINCTURE
tincture of benzoin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12745-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12745-109-01 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/15/1954 2 NDC:12745-109-02 118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/15/1954 3 NDC:12745-109-03 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/15/1954 4 NDC:12745-109-04 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/15/1954 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/15/1954 Labeler - Medical Chemical Corporation (008496861) Establishment Name Address ID/FEI Business Operations Medical Chemical Corporation 008496861 manufacture(12745-109)