DERMOVIX- allantoin,petrolatum patch 
Binger Consulting Corporation

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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Dermovix

Drug Facts

Active ingredient

Allantoin 2.00%

Petrolatum 30.00%

Purpose

Skin Protectant

Skin Protectant

Keep out of reach of children. If pregnant or breast feeding, contact physician prior to use.

Uses

• Scar Management • Temporarily protects minor cuts, scrapes and burns

Warnings

For external use only

Do not use

• on deep or puncture wounds, animal bites, serious burns

• in large quantities, particularly over raw surfaces or blistered areas

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• condition worsens symptoms last more than 7 days or clear up and occur again within a few days

Directions adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily

How to apply

• clean and dry affected area

• cut open pouch and remove patch

• remove protective film and apply directly to area

• apply to affected area not more than 3 times daily

• wash hands with soap after applying patch

• reseal pouch containing unused patches

Other ingredients lidocaine, vitamin E, onion extract

Questions or comments? call weekdays from 9 AM to 5 PM PST (888) 501-5651

Other information store below 25°C (77° F), avoid direct sunlight

Packaging

Dermovixlbel

DERMOVIX 
allantoin,petrolatum patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69440-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN2 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIDOCAINE (UNII: 98PI200987)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ONION (UNII: 492225Q21H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69440-009-1515 in 1 BOX01/01/2015
1100 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2015
Labeler - Binger Consulting Corporation (079635976)
Establishment
NameAddressID/FEIBusiness Operations
Active Intelligence, LLC080416593manufacture(69440-009)

Revised: 10/2021
Document Id: 8546bcf1-481e-4142-87f3-0c95fb3927b1
Set id: 33139e68-3714-41e8-a3a7-24f28e8b409b
Version: 3
Effective Time: 20211011
 
Binger Consulting Corporation