DERMAPHOR- skin protectant ointment 
DermaRite Industries, 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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DERMAPHOR

Active Ingredient:

Petrolatum 44.28%

Purpose:

Skin Protectant

Uses:

Warnings:

​For external use only.

Warnings:

Avoid contact with eyes. In case of contact, flush thoroughly with water.

Warnings:

Stop and ask a doctor if

​Warnings:

Do not use ​on deep or puncture wounds, animal bites, or serious wounds.

​Warnings:

Keep out of reach of children.

​Incase of accidental ingestion contact a Physician or Poison Control Center right away.

Directions:

Apply liberally to affected area as needed.

Other Information:

Inactive Ingredients:

Mineral Oil, Paraffin, Lanolin Alcohol

Questions?:

Call 800-337-6296 Mon - Fri 9AM - 5PM EST.

DermaPhor Package Label and Principal Display Panel

Case labelPackage label

DERMAPHOR 
skin protectant ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-184
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM44 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61924-184-04106 g in 1 TUBE; Type 0: Not a Combination Product11/17/2016
2NDC:61924-184-08198 g in 1 TUBE; Type 0: Not a Combination Product11/17/2016
3NDC:61924-184-16454 g in 1 JAR; Type 0: Not a Combination Product11/17/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/17/2016
Labeler - DermaRite Industries, LLC (883925562)
Registrant - DermaRite Industries, LLC (883925562)
Establishment
NameAddressID/FEIBusiness Operations
DermaRite Industries, LLC883925562manufacture(61924-184)

Revised: 1/2020
Document Id: 9c591e3e-8c57-b0c4-e053-2995a90aea13
Set id: 5bc37618-d27f-6a4d-e053-2991aa0ab247
Version: 3
Effective Time: 20200117
 
DermaRite Industries, LLC