BENZOIN COMPOUND TINCTURE PROFESSIONAL PACK- benzoin resin liquid
Humco Holding Group, Inc.

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.

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Humco Benzoin Compound Tincture, USP Professional Pack

Drug Facts

Active Ingredient

Benzoin

Purpose

Pral mucosal protectant

Use

Forms a coating over wound for protecting recurring canker sores

Warnings

For expternal 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 dentiest or doctor.

Other information

Flammable: Keep away from spark, heat or flame.

Inactive Ingredients

Alcohol 77%, Aloe, Storax, Tolu Balsam

Principal Display Panel - 2 fl oz

Label

2 fl oz

BENZOIN COMPOUND TINCTURE PROFESSIONAL PACK
benzoin resin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-4209
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:0395-4209-92	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2017	09/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	03/25/1998	09/30/2020

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc.		825672884	manufacture(0395-4209) , analysis(0395-4209) , pack(0395-4209) , label(0395-4209)

Revised: 6/2020

Document Id: a8760d26-3891-ddd9-e053-2a95a90a2924

Set id: df1e4dcb-824a-40c7-b4c0-63a37633136f

Version: 3

Effective Time: 20200619

Humco Holding Group, Inc.