Antibacterial Bathing Cloth
FDA Label NDC 63517-210

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, Inc. for the product Antibacterial Bathing (NDC 63517-210). 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, uses, warnings, ask a doctor before you use if you have:, keep out of reach of children., do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

  • to decrease bacteria on skin

Warnings

For external use only

Do not heat sealed package in microwave

Ask A Doctor Before You Use If You Have:

  • Deep puncture wounds
  • Animal bites
  • Serious burns

Keep Out Of Reach Of Children.

  • In case of accidental ingestion seek medical help or contact a Poison Control Center immediately.
  • Gloves diminish sensitivity to heat
  • Closely monitor heat level with infants, unresponsive or skin sensitive individuals

Do Not Use

  • In the eye
  • Longer than 1 week unless directed by a physician
  • Over raw surfaces or blistered areas

Directions

  • Cloths can be used at room temperature or heated in a wipes warmer for extra comfort. Warming Instructions:
  • single warming session at temperatures not to exceed 52˚C (125˚F) and
  • for a maximum of 200 hours.
  • Discard wipes that have been exposed to warming temperatures exceeding 52˚C (125˚F) or
  • stored longer than 200 hours in the warmer. Bathing Instructions:
  • Remove one cloth at a time to clean each area in the following order: 1. Neck & facial area; 2. Front torso; 3. Right arm; 4. Left arm; 5. Right leg; 6. Left leg; 7. Back torso; 8. Buttocks & perineal area
  • Allow skin to dry
  • Dispose of cloth in waste receptacle
  • Do not flush cloths in toilet

Inactive Ingredients

Aqua, Phenoxyethanol, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Myristamidopropyl PG-Dimonium Chloride Phosphate, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Citric Acid, Disodium EDTA, Allantoin.

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