BENZ PROTECT- benzoin resin liquid

Benz Protect by

Drug Labeling and Warnings

Benz Protect by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzoin Compound Tincture (Benzoin, Aloe, Storax, Tolu, Balsam, Alcohol)

Intended Use

• Forms a coating over a wound
• For protecting recurring canker sores

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

Do not

• Use this product for more than 7 days unless directed by a dentist or doctor
• Exceed recommended dosage

Stop use and ask a dentist or doctor if

• Sore mouth symptoms do not improve in 7 days
• Irritation, pain, or redness persists or worsens
• Swelling, rash, or fever develop

Directions

Adults and children 6 months or age and older: Dry affected area of oral mucosa. Apply the swab applicator every 3-4 hours or as directed by physician. Children under 6 months of age: Consult a dentist or Doctor

STORAGE AND HANDLING

Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Avoid exposure
to direct sunlight or heat.

KEEP OUT OF REACH OF CHILDREN.

In case of accidental ingestions, seek professional assistance or contact a Poison Control Center immediately

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

INACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZ PROTECT 
benzoin resin liquid

Product 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)