DERMAGESIC- pramoxine hcl, zinc oxide, calamine liquid

Dermagesic by

Drug Labeling and Warnings

Dermagesic by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceuticals International Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                   Purpose

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

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

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

PURPOSE

Purpose

Anesthetic/Analgesic

Skin Protectant

INDICATIONS & USAGE

Uses

• for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor irritations
• dries the oozing and weeping of poison ivy, poison oak and poison sumac.

WARNINGS

Warnings

• For external use only. Avoid contact with the eyes
• Not for Pediatric use
• Hypersensitivity to "caine" anesthetics
   

DO NOT USE

Do not use

• on large areas of the body
• with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

• on chicken pox
• on measles

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

• symptoms persist for more than 7 days or clear up and occur again within a few 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.
 

DOSAGE & ADMINISTRATION

Directions  SHAKE WELL

• Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily
• Children under 2 years of age ask a doctor
• Do not use more often than directed

INACTIVE INGREDIENT

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

Questions:  1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMAGESIC 
pramoxine hcl, zinc oxide, calamine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.4 mg  in 100 mL
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.4 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-120-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	01/01/2014

Labeler - Llorens Pharmaceuticals International Division (037342305)