DERMAGESIC- pramoxine hcl, zinc oxide, calamine cream

Dermagesic by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Pramoxine HCl 1%

Zinc Oxide 0.4%

Calamine 0.4%

Purpose

Anestheric/Analgesic

Skin Protectant

Uses

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

Warnings

For external use only. Avoid contact with the eyes

• Not for Pediatric use
• Hypersensitivity to "caine" anesthetics

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.

Directions 

• 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 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMAGESIC 
pramoxine hcl, zinc oxide, calamine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4 mg  in 1 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-202-04	113 g in 1 JAR; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	04/01/2016

Labeler - Llorens Pharmaceutical International Division (037342305)