Dermarest Eczema Medicated Moist for Sensitive Skin

Dosage form: cream
Ingredients: Pramoxine Hydrochloride 1g in 57g
Labeler: Insight Pharmaceuticals LLC
NDC Code: 63736-325

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.

Dermarest Eczema
Medicated Moisturizer
for Sensitive Skin

Drug Facts

Active ingredient

Pramoxine hydrochloride 1%

Purpose

Topical analgesic

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

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   ECZEMA MEDICATED MOIST FOR SENSITIVE SKIN
pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-325
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride1 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63736-325-241 TUBE in 1 CARTON
156.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34807/23/2010
Labeler - Insight Pharmaceuticals LLC (176792315)

Revised: 05/2012
 
Insight Pharmaceuticals LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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