Label: BENZOIN TINCTURE- benzoin resin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0395-9107-92 - Packager: Humco Holding Group, Inc.
- Category: HUMAN OTC DRUG LABEL
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 June 19, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and consult a dentist or doctor if
- Keep out of reach of children.
- Directions
- Other information
- Inactive Ingredients
- SM
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INGREDIENTS AND APPEARANCE
BENZOIN TINCTURE
benzoin resin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN 1000 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALOE (UNII: V5VD430YW9) TOLU BALSAM (UNII: TD2LE91MBE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-9107-92 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/12/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/01/2008 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc. 825672884 manufacture(0395-9107) , analysis(0395-9107) , pack(0395-9107) , label(0395-9107)