COMPOUND BENZOIN TINCTURE- tincture of benzoin liquid 
Medical Chemical Corporation

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.

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Compound Benzoin Tincture Label

Active Ingredients: Aloe, Benzoin, Storax, Tolu Balsam, Ethanol

Purpose: Antiseptic

Warnings: Keep out of reach of children.  Ingestion will result in severe gastrointestinal distress, unconsciousness and death.  If ingested induce vomiting if the victim is conscious.  Contact a poison control center immediately.

Directions: Apply to affected area for first-aid treatment of minor cuts and abrasions.  Discontinue use and get medical aid if redness, irritation or infection develops.  In case of deep or puncture wounds consult a physician.

Warnings: Keep out of reach of children.  Ingestion will result in a severe gastrointestinal distress, unconsciousness and death.  If ingested induce vomiting if victim is conscious.  Contact a poison control center immediately.

Directions: Apply to affected area for first-aid treatment of minor cuts and abrasions.  Discontinue use and get medical aid if redness, irritation or infection develops.  In case of deep or puncture wounds consult a physician.

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Compound Benzoin Tincture Label

COMPOUND BENZOIN TINCTURE 
tincture of benzoin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12745-109-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/1954
2NDC:12745-109-02118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/15/1954
3NDC:12745-109-03118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/15/1954
4NDC:12745-109-04473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1954
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/1954
Labeler - Medical Chemical Corporation (008496861)
Establishment
NameAddressID/FEIBusiness Operations
Medical Chemical Corporation008496861manufacture(12745-109)

Revised: 1/2022
Document Id: d5cfacaa-d277-acef-e053-2995a90a9e25
Set id: 243494ee-342d-4c32-9a86-f8c6c347bd8b
Version: 17
Effective Time: 20220117
 
Medical Chemical Corporation