Label: BENZ PROTECT- benzoin resin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-099-10, 54162-099-50 - Packager: Geritrex LLC
- 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 October 27, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Intended Use
- Directions
- Warnings
- Stop use and ask a dentist or doctor if
- Directions
- STORAGE AND HANDLING
- KEEP OUT OF REACH OF CHILDREN.
- PREGNANCY OR BREAST FEEDING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENZ PROTECT
benzoin resin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-099 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALOE (UNII: V5VD430YW9) LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93) TOLU BALSAM (UNII: TD2LE91MBE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-099-10 3 mL in 1 POUCH; Type 0: Not a Combination Product 10/27/2017 2 NDC:54162-099-50 150 mL in 1 BOX; Type 0: Not a Combination Product 10/27/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/31/2015 Labeler - Geritrex LLC (112796248) Registrant - Geritrex LLC (112796248)