Antibacterial Bathing Wipe

Antibacterial Bathing Wipe
SPL v5
SPL
SPL Set ID 586463f3-d117-47ae-bbab-f7caff1f5fa8
Route
TOPICAL
Published
Effective Date 2019-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Phenoxyethanol Sodium Benzoate Aloe Vera Leaf Myristamidopropyl Propylene Glycol-dimonium Chloride Phosphate Linoleamidopropyl Propylene Glycol-dimonium Chloride Phosphate Citric Acid Monohydrate Edetate Disodium Allantoin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-15

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Uses
  • to decrease bacteria on skin
Warnings

For external use only

Do not heat sealed package in microwave

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
Do Not Use
  • In the eye
  • Longer than 1 week unless directed by a physician
  • Over raw surfaces or blistered areas
Active Ingredient

Benzalkonium Chloride 0.13%

Package Labeling:

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.

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
Ask A Doctor Before You Use If You Have:
  • Deep puncture wounds
  • Animal bites
  • Serious burns

Structured Label Content

Uses
  • to decrease bacteria on skin
Purpose

Antiseptic

Warnings

For external use only

Do not heat sealed package in microwave

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
Do Not Use (Do not use)
  • In the eye
  • Longer than 1 week unless directed by a physician
  • Over raw surfaces or blistered areas
Active Ingredient

Benzalkonium Chloride 0.13%

Package Labeling:

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.

Keep Out of Reach of Children. (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
Ask A Doctor Before You Use If You Have: (Ask a doctor before you use if you have:)
  • Deep puncture wounds
  • Animal bites
  • Serious burns

Advanced Ingredient Data


Raw Label Data

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