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 Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoin

Purpose

Oral mucosal protectant

Use

Forms a coating over wound for protecting recurring canker sores

Warnings

For external 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 for 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 reach of children.

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

Directions

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

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

Other information

Flammable: Keep away from spark, heat or flame.

Inactive Ingredients

Alcohol 77%, Aloe, Storax, Tolu Balsam

Principal Display Panel - 16oz

Principal Display Panel - 2 oz

INGREDIENTS AND APPEARANCE

BENZOIN COMPOUND TINCTURE 
benzoin resin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-0243
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-0243-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2017
2	NDC: 0395-0243-92	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2008

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-0243) , analysis(0395-0243) , pack(0395-0243) , label(0395-0243)