Nu-derm Tolereen
FDA Label NDC 62032-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Omp, Inc. for the product Nu-derm Tolereen (NDC 62032-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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)

Principal Display Panel (57g Bottle Carton)

Principal Display Panel (57g Bottle Carton)

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