4-n-1 Wash
FDA Label NDC 61924-208

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermarite Industries, Llc for the product 4-n-1 Wash (NDC 61924-208). 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 ingredients:, purpose:, uses:, warnings:, directions:, other information:, ingredients:, 4-n-1 wash cream package label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Dimethicone 1%

Purpose:

Skin Protectant

Uses:

  • A gentle alternative to soap and water.
  •  Cleans, restores, nourishes, and protects even most delicate skin.
  •  Ideal for frequent cleansing and incontinence care.

Warnings:

  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask a doctor if – condition worsens or does not improve within 7 days; symptoms clear up and occur again within a few days.
  • Do not use on deep puncture wounds, animal bites, or serious burns.
    • Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions:

  • For skin care: Apply quarter-sized amount to warm, damp cloth. Wash skin, turning the cloth as the skin is cleansed to remove residue.
  • For incontinence care: Remove excess fecal matter. Follow skin care directions above

Other Information:

Store at room temperature (59°-86°F)

Ingredients:

Butylparaben, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Ehtylparaben, Fragrance, Glyceryl Stearate, Isobutylparaben, Methyl paraben, PEG-100 Stearate, PEG-20 Glyceryl Stearate, Phenoxyethanol, Propylparaben, Water

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