Opi Antiseptic Foaming Hand Cleaner
FDA Label NDC 43196-510

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Opi Correctional Industries for the product Opi Antiseptic Foaming Hand Cleaner (NDC 43196-510). 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 ingredient:, purpose:, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient:

Chloroxylenol (1.49% w/w)

Purpose:

Anti-Microbial Hand Cleanser

Uses

  • Helps reduce bacteria that potentially can cause disease
  • Helps prevent cross contamination by hand contact

Warnings

  • For external use only

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.
  • In case of eye contact flush with water for 15 minutes, if irritation persists, get medical attention.
  • In case of accidental ingestion, seek medical attention or contact a poison control center immediately.
  • This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
  • Do not contaminate water, food or feed by storage and disposal.

Directions

  • Apply cleaner to palm of hand
  • Lather and scrub hands (including fingers, wrist, and cuticles) vigorously for 60 seconds
  • Rinse with water until all cleaner is removed from hands
  • Dry completely (incomplete drying may lead to chapped skin).

Inactive Ingredients

Water, 2-Propanol, Sodium Laureth Sulfate, Cocoamidopropyl Betaine, Cocoamphoproprionate,

Cocoamide, Hydroxyethyl Cellulose, Triclosan

Principal Display Panel

Bottle Label:

OPI

PERSONAL CARE SUPPLIES

ANTISEPTIC FOAMING HAND CLEANER

An Anti-Microbial Lotion Hand

Wash Formulated To Clean

Effectively, Yet Gently.

See side panel for additional information.

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Principal Display Panel (Opi00 0000 01)

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