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Sunmark Benzoin Compound Tincture

Medically reviewed on December 12, 2017

Dosage form: liquid
Ingredients: BENZOIN RESIN 1000mg in 1mL
Labeler: McKesson
NDC Code: 49348-138

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.

Sunmark Benzoin Compound Tincture, NFXI

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

Principal Display Panel - 2 oz

Label

SUNMARK BENZOIN COMPOUND TINCTURE 
benzoin resin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-138
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOIN RESIN (BENZOIN RESIN) BENZOIN RESIN1000 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ALOE 
TOLU BALSAM 
Packaging
#Item CodePackage Description
1NDC:49348-138-3059 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/01/2008
Labeler - McKesson (177667227)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc.825672884manufacture(49348-138), analysis(49348-138), pack(49348-138), label(49348-138)

 
McKesson

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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