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

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LLorens-Dermagesic Cream

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 DrugM01704/01/2016
Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 12/2024
Document Id: 29a87e67-56d0-a2b0-e063-6394a90a1f9b
Set id: bbff6b53-29da-45c1-8ccd-3e9df7f250e0
Version: 6
Effective Time: 20241219
 
Llorens Pharmaceutical International Division