COMPOUND BENZOIN- compound benzoin tincture
Paddock Laboratories, LLC

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.

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Perrigo Compound Benzoin Tincture USP

Active ingredient

Benzoin compound tincture

Purpose

oral mucosal protectant

Uses

Forms a coating over a wound
For protecting recurring canker sores

Warnings

Do not

use this product for more than 7 days unless directed by a dentist or doctor
exceed recommended dosage

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

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions

Adults and children 6 months of age and older: Dry the affected area. Saturate a cotton applicator with medication. Apply the undiluted medication directly to the affected area. Do not use more than every 2 hours.

Children under 6 months of age: Consult a dentist or doctor.

Other information

Do not use if Tamper Evident Seal is broken or missing. The product is sealed with either a shrink band imprinted with “Sealed for Your Protection” or breakaway cap ring.
Store at 20 o to 25 oC (68 o to 77 oF) [see USP Controlled Room Temperature] in tight, light-resistant containers.

Avoid exposure to direct sunlight and excessive heat.

Questions?

1-800-719-9260

Serious side effects associated with use of this product may be reported to this number.

Inactive ingredients

Benzoin, Aloe, Storax, Tolu Batsam, Alcohol

Package/Label Principal Display Panel

NDC 0574- 9119-02

Compound Benzoin Tincture USP

Alcohol 77%

Oral Mucosal Protectant

SAFETY SEALED

FLAMMABLE:

Keep away from spark, heat and flame.

2 FL OZ (59 mL)

COMPOUND BENZOIN
compound benzoin tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0574-9119
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R)	BENZOIN RESIN	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93)
TOLU BALSAM (UNII: TD2LE91MBE)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0574-9119-02	59 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/06/2017	11/09/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	04/02/2014	11/09/2018

Labeler - Paddock Laboratories, LLC (967694121)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc.		825672884	manufacture(0574-9119) , analysis(0574-9119) , pack(0574-9119) , label(0574-9119)

Revised: 11/2018

Document Id: 7a3e1208-8e8c-2ba4-e053-2991aa0af5bd

Set id: 8c08a567-d7ee-4f8b-847e-00dbeb6decdb

Version: 3

Effective Time: 20181109

Paddock Laboratories, LLC