BENZOIN COMPOUND TINCTURE- benzoin resin liquid

Benzoin Compound Tincture by

Drug Labeling and Warnings

Benzoin Compound Tincture by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC, Frutarom. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Benzoin Resin

STORAGE AND HANDLING

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

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZOIN COMPOUND TINCTURE 
benzoin resin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-100
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: 54162-100-02	58 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2015
2	NDC: 54162-100-01	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2015
3	NDC: 54162-100-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2015

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)

Establishment
Name	Address	ID/FEI	Business Operations
Frutarom		237870915	manufacture(54162-100)