Drug Facts

Active Ingredient

Benzoin

Purpose

Oral mucosal protectant

Use

Forms a coating over wound for protecting recurring canker sores

Warnings

For externl use only. Do not swallow. Do not exceed recommended dosage.

When using this product

Children under 12 years of age should be supervised in the use of this product.

Do not use more than 7 days unless directed by a dentist or doctor.

Stop use and consult 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 develops.

Keep out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immeditely.

Directions

Adult and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more than every 2 hours.

Children under 6 months of age: Consult a dentist or doctor.

Inactive Ingredients

Alcohol 77%, Aloe, Stoax, tolu Balsam.

Questions or Comments?

1-800-662-3435

Principal Display Panel

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BENZOIN TINCTURE
benzoin resin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-0247
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R)	BENZOIN RESIN	1000 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ALOE (UNII: V5VD430YW9)
TOLU BALSAM (UNII: TD2LE91MBE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0395-0247-92	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	01/01/2008

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(0395-0247) , analysis(0395-0247) , pack(0395-0247) , label(0395-0247)

Humco Benzoin Tincture, NF