NU-DERM Tolereen Anti-pruritic

Dosage form: lotion
Ingredients: Hydrocortisone 5mg in 1g
Labeler: OMP, Inc.
NDC Code: 62032-112

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.

OBAGI
NU-DERM®
TOLEREEN

Drug Facts

Active ingredients

Hydrocortisone, 0.5%

Purpose

Anti-itch

Uses
  • Provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes from:
    • Eczema
    • Psoriasis
    • Insect bites
    • Seborrheic dermatitis
    • Soaps
    • Poison ivy
    • Poison oak
    • Poison sumac
    • Jewelry
    • Cosmetics
    • Detergents
  • Other uses of this product should be only under the advice and supervision of a doctor.

Warnings
  • For external use only.

Do not use
  • In the eyes.
  • For the treatment of diaper rash.

When using this product do not begin the use of any other hydrocortisone product.

Stop use and ask a doctor if

  • Symptoms last for more than 7 days.
  • The condition gets worse.
  • Symptoms clear up and come back in a few days.

Keep out of the reach of children.

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

Directions
  • Adults and children 2 years and older: apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years of age, do not use, ask a doctor.

Other information
  • Store at room temperature. Protect from freezing and excessive heat.

Inactive ingredients

allantoin, butylparaben, cetyl alcohol, cyclopentasiloxane, glycerin, glyceryl stearate, lactic acid, methylparaben, PEG-100 stearate, propylparaben, purified water, saponins, stearyl alcohol, tetrasodium EDTA.

Dist. by OMP, Inc., Long Beach, CA 90802

PRINCIPAL DISPLAY PANEL - 57g Bottle Carton

OBAGI
NU-DERM®

TOLEREEN

ANTI-PRURITIC
LOTION

HYDROCORTISONE
USP, 0.5%

NET WT. 2 OZ. (57g)

NU-DERM TOLEREEN   ANTI-PRURITIC
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-112
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STEARYL ALCOHOL 
CYCLOMETHICONE 5 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
CETYL ALCOHOL 
GLYCERIN 
LACTIC ACID 
METHYLPARABEN 
ALLANTOIN 
PROPYLPARABEN 
EDETATE SODIUM 
BUTYLPARABEN 
WATER 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62032-112-361 BOTTLE, PLASTIC (BOTTLE) in 1 BOX
157 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/01/1988
Labeler - OMP, Inc. (790553353)
Establishment
NameAddressID/FEIOperations
Puretek Corporation785961046MANUFACTURE(62032-112), LABEL(62032-112), PACK(62032-112)

Revised: 10/2011
 
OMP, Inc.

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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