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Dermarest

Insight Pharmaceuticals LLC

Dermarest Eczema Medicated Moisturizer for Sensitive Skin


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Pramoxine hydrochloride 1%

Purpose

Topical analgesic

Dermarest Uses

for the temporary relief of pain and itching associated with

  • minor burns
  • minor cuts
  • scrapes
  • minor skin irritations

Warnings

For external use only

Do not use

  • in or around the eyes
  • more often than directed
  • longer than 1 week

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

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

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: consult a doctor

Dermarest Other information

Keep carton for full drug facts.

Inactive ingredients

Water, butylene glycol, hamamelis virginiana (witch hazel) water, propylene glycol dicaprylate/dicaprate, cyclopentasiloxane, myristyl alcohol, octyldodecanol, glyceryl stearate, polyquaternium-37, cyclohexasiloxane, hydrogenated polyisobutene, aleurites moluccana seed oil, tocopheryl acetate, zinc PCA, panthenol, camellia sinensis leaf extract, ceramide 3, chamomilla recutita (matricaria) flower extract, aloe barbadensis leaf juice, allantoin, ceramide 6 II, ceramide 1, hydroxyphenyl propamidobenzoic acid, pentylene glycol, PPG-1 trideceth-6, propylene glycol, sodium hydroxide, disodium EDTA, caprylyl glycol, 1, 2-hexanediol

Questions?

call 1-800-344-7239 or visit our website at www.dermarest.com

Distributed by:
INSIGHT Pharmaceuticals, LLC. Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

New Look!

Dermarest

Eczema
Medicated Moisturizer
for Sensitive Skin

With skin soothing
zinc complex

  • Relieves itchy, dry skin
  • Restores moisture
  • Comforts sensitive skin
  • Fragrance free

24 hour itch relief*

Pramoxine
Hydrochloride 1%
Topical Analgesic

Dermatologist
TESTED

2 FL OZ (56.7 g)

Dermarest

Dermarest

Pramoxine Hydrochloride CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-325
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
pramoxine hydrochloride PRAMOXINE 1 g

Inactive Ingredients

Ingredient Name Strength
water
BUTYLENE GLYCOL
WITCH HAZEL
propylene glycol dicaprylate
CYCLOMETHICONE 5
MYRISTYL ALCOHOL
OCTYLDODECANOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
CYCLOMETHICONE 6
.ALPHA.-TOCOPHEROL ACETATE, D-
Zinc
PANTHENOL
GREEN TEA LEAF
Matricaria Recutita
Aloe Vera Leaf
ALLANTOIN
XANTHAN GUM
PENTYLENE GLYCOL
propylene glycol
SODIUM HYDROXIDE
EDETATE DISODIUM
ALCOHOL

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 56.7 in 1 TUBE
2 NDC:63736-325-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2010-07-23


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Be sure to consult your doctor before taking any medication!
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