humco benzoin tincture, nf

humco benzoin tincture, nf
SPL v5
SPL
SPL Set ID b33b5896-673b-498c-8a58-76ece8552f7a
Route
topical
Published
Effective Date 2013-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzoin resin (1000 mg)
Inactive Ingredients
alcohol aloe tolu balsam

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2008-01-01

Purpose

Oral mucosal protectant

Description

Drug Facts


Medication Information

Warnings

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

Purpose

Oral mucosal protectant

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.

Description

Drug Facts

Principal Display Panel

Use

Forms a coating over wound for protecting recurring canker sores

Section 42229-5

Drug Facts

Active Ingredient

Benzoin

Questions Or Comments?

1-800-662-3435

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.

Keep Out of the Reach of Children.

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

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.

Structured Label Content

Warnings

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

Purpose

Oral mucosal protectant

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.

Principal Display Panel

Use

Forms a coating over wound for protecting recurring canker sores

Section 42229-5 (42229-5)

Drug Facts

Active Ingredient

Benzoin

Questions Or Comments? (Questions or Comments?)

1-800-662-3435

When Using This Product (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.

Keep Out of the Reach of Children. (Keep out of the reach of children.)

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

Stop Use and Consult A Dentist Or Doctor If (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.

Advanced Ingredient Data


Raw Label Data

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