Private Label Benzoin Tincture

Private Label Benzoin Tincture
SPL v2
SPL
SPL Set ID e42fccc2-1b4f-e7f3-e053-2a95a90aef39
Route
TOPICAL
Published
Effective Date 2014-04-01
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

Description

Drug Facts

Purpose

Protectant


Medication Information

Purpose

Protectant

Description

Drug Facts

Sm

Use

Forms a coating over wound for protecting recurring canker sores

Section 42229-5

Drug Facts

Warnings

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

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.

Active Ingredient

Benzoin

Other Information

Flammable: Keep away from spark, heat or flame.

Inactive Ingredients

Alcohol 77%, Aloe, Storax, Tolu Balsam

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.

Keep Out of Reach of Children.

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

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

Sm (SM)

Use

Forms a coating over wound for protecting recurring canker sores

Section 42229-5 (42229-5)

Drug Facts

Purpose

Protectant

Warnings

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

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.

Active Ingredient

Benzoin

Other Information (Other information)

Flammable: Keep away from spark, heat or flame.

Inactive Ingredients

Alcohol 77%, Aloe, Storax, Tolu Balsam

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 for more than 7 days unless directed by a dentist or doctor.

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

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

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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