DERMAGESIC- pramoxine hcl, zinc oxide, calamine cream 
Llorens Pharmaceutical International Division

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.

----------

Active Ingredients

Pramoxine HCl 1%

Zinc Oxide 0.4%

Calamine 0.4%

Purpose

Anestheric/Analgesic

Skin Protectant

Uses

Warnings

For external use only. Avoid contact with the eyes

Do not use

Ask a doctor before use

Stop use and ask a doctor if condition worsens or does not improve within 7 days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions 

Inactive Ingredients

Aloe Badbadensis Leaf juice (Aloe Vera), Avena Sativa (Oat) Kernal colloidal, cetyl stearyl alcohol, ceteareth-6, ceteareth-25, diazolidinyl urea, fragrance, menthol, methyl paraben, paraffinum liquidum, propylene glycol, propyl paraben, purified water, stearyl alcohol

Questions or Comments

1-866-595-5598

Dermagesic Cream

DERMAGESIC 
pramoxine hcl, zinc oxide, calamine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 mg  in 1 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARETH-6 (UNII: 2RJS3559D3)  
CETEARETH-25 (UNII: 8FA93U5T67)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-202-04113 g in 1 JAR; Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34704/01/2016
Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 12/2020
Document Id: 3bc1d84a-63d6-4bde-b953-2e76539339fe
Set id: bbff6b53-29da-45c1-8ccd-3e9df7f250e0
Version: 4
Effective Time: 20201223
 
Llorens Pharmaceutical International Division