BENZOIN TINCTURE- 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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Private Label Benzoin Tincture

Drug Facts

Active Ingredient

Benzoin

Purpose

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 dentiest or doctor.

Other information

Flammable: Keep away from spark, heat or flame.

Inactive Ingredients

Alcohol 77%, Aloe, Storax, Tolu Balsam

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BENZOIN TINCTURE 
benzoin resin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN1000 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALOE (UNII: V5VD430YW9)  
TOLU BALSAM (UNII: TD2LE91MBE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9107-9259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2008
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884manufacture(0395-9107) , analysis(0395-9107) , pack(0395-9107) , label(0395-9107)

Revised: 6/2020
Document Id: a878b139-8995-e154-e053-2995a90a621e
Set id: 60517f09-674c-ea0c-e053-2991aa0a9b92
Version: 3
Effective Time: 20200619
 
Humco Holding Group, Inc.