BENZ PROTECT- benzoin resin liquid 
Geritrex 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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Benz Protect

Active Ingredient

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

Intended Use

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.

Warnings

Do not

Stop use and ask a dentist or doctor if

Directions

Adults and children 6 months or age and older: Dry affected area of oral mucosa. Apply the swab applicator every 3-4 hours or as directed by physician. Children under 6 months of age: Consult a dentist or Doctor

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.

KEEP OUT OF REACH OF CHILDREN.

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

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

image description

BENZ PROTECT 
benzoin resin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALOE (UNII: V5VD430YW9)  
LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93)  
TOLU BALSAM (UNII: TD2LE91MBE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-099-103 mL in 1 POUCH; Type 0: Not a Combination Product10/27/2017
2NDC:54162-099-50150 mL in 1 BOX; Type 0: Not a Combination Product10/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/31/2015
Labeler - Geritrex LLC (112796248)
Registrant - Geritrex LLC (112796248)

Revised: 10/2017
Document Id: 5f075dba-c590-41bc-979d-5c69c93a8a16
Set id: 28e2879c-73c7-4715-b944-ebd0df3cec4f
Version: 2
Effective Time: 20171027
 
Geritrex LLC