BENZOIN TINCTURE- benzoin resin liquid

Benzoin Tincture by

Drug Labeling and Warnings

Benzoin Tincture by is a Otc medication manufactured, distributed, or labeled by 116956644, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoin Tincture

Purpose

Oral mucosal protectant

Use

Forms a coating over wound for protecting recurring canker sores

Warnings

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

When using this product

do not use in the eyes

do not use this product for longer than 1 week unless directed by a dentist or doctor

Stop use and consult a dentist or doctor if

• the condition persists or gets worse
• symptoms do not improve in 7 days.
• pain, irritation, swelling, redness, rash or fever develop

Keep out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immeditely. (1-800-222-1222)

Directions

Adult and children 6 months of age and older: Dry the affected area. Saturate a cotton applicator with medication and 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 79%, Aloe, Stoax, Tolu Balsam.

Questions?

Call 833-358-6431

Principal Display Panel

INGREDIENTS AND APPEARANCE

BENZOIN TINCTURE 
benzoin resin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R)	BENZOIN RESIN	1000 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE (UNII: V5VD430YW9)
TOLU BALSAM (UNII: TD2LE91MBE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1200-1	59 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	12/17/2024

Labeler - 116956644 (116956644)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(70677-1200) , analysis(70677-1200) , pack(70677-1200) , label(70677-1200)