FDA Label for Nu-derm Tolereen Anti-pruritic

View Indications, Usage & Precautions

Nu-derm Tolereen Anti-pruritic Product Label

The following document was submitted to the FDA by the labeler of this product Omp, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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.

Otc - When Using



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


Otc - Stop Use



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.

Otc - Keep Out Of Reach Of Children



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.


Principal Display Panel - 57G Bottle Carton



OBAGI
NU-DERM®

TOLEREEN

ANTI-PRURITIC
LOTION

HYDROCORTISONE
USP, 0.5%

NET WT. 2 OZ. (57g)


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