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Benzoin Compound Tincture by Geritrex LLC

Medically reviewed on Jan 17, 2018

Dosage form: liquid
Ingredients: BENZOIN RESIN 100mg in 1mL
Labeler: Geritrex LLC
NDC Code: 54162-100

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.

Benzoin Compound Tincture

Active Ingredient

Tincture Benzoin compound

Intended Use

Antiseptic preparation maintains skin
integrity and protects skin from adhesive and harsh body
fluids. Forms a fine coating over skin, abrasions, wounds
and oral lesions.

Directions

For adults and supervised children 2 years and older:
Dry affected area of skin or oral mucosa. Apply with a cotton
swab or gauze every 3-4 hours or as directed by your physician.

Warnings

For external use only.
Do not apply to or near eyes. Do not swallow. In case of accidental
ingestion seek professional assistance or contact poison control
center immediately.
FLAMMABLE: Keep away from sparks, heat and flames.
When using this product:
Discontinue use and consult a physician if irritation persists,
worsens or if swelling or rash develops. Do not use for more
than 10 days unless directed by your physician.

Apply with a cotton
swab or gauze every 3-4 hours

Benzoin Resin

To be stored at room temperature 15-30°C (59-86°F). Avoid exposure
to direct sunlight or heat.

KEEP OUT OF REACH OF CHILDREN.





BENZOIN COMPOUND TINCTURE 
benzoin resin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOIN RESIN (BENZOIN RESIN) BENZOIN RESIN100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ALOE 
LIQUIDAMBAR ORIENTALIS RESIN 
TOLU BALSAM 
Packaging
#Item CodePackage Description
1NDC:54162-100-0258 mL in 1 BOTTLE, PLASTIC
2NDC:54162-100-0129 mL in 1 BOTTLE, PLASTIC
3NDC:54162-100-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/31/2015
Labeler - Geritrex LLC (112796248)
Registrant - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIOperations
Frutarom237870915manufacture(54162-100)

 
Geritrex LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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