Loesch
FDA Label NDC 25280-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Loesch Laboratory Consultants, Inc. for the product Loesch (NDC 25280-004). 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 active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrocortisone, USP (0.5%)

Purpose

Anti-Itch

Use

  • Specially formulated to rapidly and completely penetrate the scalp (or skin) delivering itch relief anywhere it's needed.
  • This liquid preparation can be applied to the skin or scalp to temporarily relieve minor itching and skin irritations commonly associated with insect bites, poison oak, poison sumac, and skin blemishes.

Warnings

  • Not for use on children under 2 years old except as directed by a pediatrician.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to large areas of the body and do not use for extended periods of time.
  • For external use only.
  • If irritation develops and persists, discontinue use and ask a doctor.
  • When using this product, if condition worsens or if symptoms persists for more than 7 days or clear up and occur again within a few days, stop use and ask a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Apply this product topically to affected areas and allow to dry without rubbing.
  • Use up to 3 times daily.
  • Use only as directed.

Other Information

  • External antipruritic

Inactive Ingredients:

Ethanol, Purified Water, Isopropyl Alcohol, Glycerin, Laureth 4, t-Butyl Alcohol, Brucine Sulfate

Questions Or Comments?

Loesch Laboratory Consultants, Inc.
4311 South Dr., Houston, TX 77053-4820
800.231.7157 M-F 8am-5pm

Image Of 2.0 Fl. Oz. Labelndc:25280-004-02

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Label (Loeschantiitchtherapy2oz)

Label (Loeschantiitchtherapy2oz)

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