FDA Label for Antibacterial Bathing

View Indications, Usage & Precautions

Antibacterial Bathing Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Package Labeling:




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