Benz Protect

Benz Protect
SPL v2
SPL
SPL Set ID 28e2879c-73c7-4715-b944-ebd0df3cec4f
Route
TOPICAL
Published
Effective Date 2017-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoin Resin (100 mg)
Inactive Ingredients
Alcohol Aloe Liquidambar Orientalis Resin Tolu Balsam

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-07-31

Description

Benzoin Compound Tincture (Benzoin, Aloe, Storax, Tolu, Balsam, Alcohol)


Medication Information

Description

Benzoin Compound Tincture (Benzoin, Aloe, Storax, Tolu, Balsam, Alcohol)

Section 44425-7

Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Avoid exposure

to direct sunlight or heat.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Do not

  • Use this product for more than 7 days unless directed by a dentist or doctor
  • Exceed recommended dosage

Directions

For adults and supervised children 2 years and older:

Dry affected area of skin or oral mucosa. Apply with a cotton

swab or gauze every 3-4 hours or as directed by your physician.

Intended Use
  • Forms a coating over a wound
  • For protecting recurring canker sores
Active Ingredient

Benzoin Compound Tincture (Benzoin, Aloe, Storax, Tolu, Balsam, Alcohol)

Keep Out of Reach of Children.

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

Stop Use and Ask 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 develop

Structured Label Content

Section 44425-7 (44425-7)

Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Avoid exposure

to direct sunlight or heat.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Do not

  • Use this product for more than 7 days unless directed by a dentist or doctor
  • Exceed recommended dosage

Directions

For adults and supervised children 2 years and older:

Dry affected area of skin or oral mucosa. Apply with a cotton

swab or gauze every 3-4 hours or as directed by your physician.

Intended Use
  • Forms a coating over a wound
  • For protecting recurring canker sores
Active Ingredient

Benzoin Compound Tincture (Benzoin, Aloe, Storax, Tolu, Balsam, Alcohol)

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

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

Stop Use and Ask A Dentist Or Doctor If (Stop use and ask 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 develop

Advanced Ingredient Data


Raw Label Data

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