DERMAGESIC- pramoxine hcl, zinc oxide, calamine liquid 
Llorens Pharmaceuticals 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.

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Active Ingredients                   Purpose

Pramozine HCl .... 1% ............ Anesthetic/Analgesic

Zinc Oxide .........0.4% ............ Skin Protectant

Calamine ...........0.4% ............ Skin Protectant

Purpose

Anesthetic/Analgesic

Skin Protectant

Uses

Warnings

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 If swallowed, get medical help or contact a Poison Control Center right away.

Directions  SHAKE WELL

Inactive Ingredients: Glycerin, glyceryl stearate, PEG-100 Stearate, cetearyl alcohol, methylparaben, propylparaben, aloe barbadensis leaf juic (aloe vera), avena sativa (oat) kernel colloidal oatmeal, fregrance, hydroxypropyl methylcellulose, menthol, purified water

Questions:  1-866-595-5598

DermagesicLabel

DERMAGESIC 
pramoxine hcl, zinc oxide, calamine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.4 mg  in 100 mL
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-120-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34701/01/2014
Labeler - Llorens Pharmaceuticals International Division (037342305)

Revised: 12/2020
Document Id: bdc7538b-60af-4dce-b072-ad2a91cb7716
Set id: 8b3f8894-1ed7-4888-a42c-8510d6161edd
Version: 2
Effective Time: 20201223
 
Llorens Pharmaceuticals International Division