DERMOVIX- allantoin,petrolatum patch

Dermovix by

Drug Labeling and Warnings

Dermovix by is a Otc medication manufactured, distributed, or labeled by Binger Consulting Corporation, Active Intelligence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Allantoin 2.00%

Petrolatum 30.00%

Purpose

Skin Protectant

Skin Protectant

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Other ingredients lidocaine, vitamin E, onion extract

QUESTIONS

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

STORAGE AND HANDLING

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

Packaging

INGREDIENTS AND APPEARANCE

DERMOVIX 
allantoin,petrolatum patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69440-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	2 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LIDOCAINE (UNII: 98PI200987)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ONION (UNII: 492225Q21H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69440-009-15	15 in 1 BOX
1		100 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2015

Labeler - Binger Consulting Corporation (079635976)

Establishment
Name	Address	ID/FEI	Business Operations
Pocono Coated Products, LLC		362785771	manufacture(69440-009)