CARDINALHEALTH ANTIBACTERIAL BATHING WIPES- benzalkonium chloride liquid
Cardinal Health 200, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CardinalHealth antibacterial bathing wipes

Active Ingredient

Benzalkonium Chloride 0.12%

Purpose

Antiseptic

Uses:

To decrease bacteria on skin.

Warnings:

For external use only.

Keep out of reach of children.

In case of accidental ingestion seek medical help or contact a Poison Control Center immediately.

Do not use:

In the eye or apply over large areas of the body
Longer than 1 week unless directed by a physician
Over raw surfaces or blistered areas.

Ask a doctor before you use if you have:

Deep puncture wounds
Animal bites
Serious burns

Directions:

Cloths can be used at room temperature or heated in a microwave for extra comfort.

Heating Instructions:

Peel back the resealable label before warmingWarm entire package in microwave for no longer than 20 seconds and test temperature to avoid burning skinAdjust warming time according to microwave wattage.

Washing Instructions:

Remove one cloth at a time to clean each area in the following order: 1. Neck and facial area; 2. Front torso; 3. Right arm; 4. Left arm; 5. Right leg; 6. Left leg; 7. Back torso; 8. Buttocks and perineal areaAllow skin to dryDispose of cloth in waste receptacle Do not flush cloths in toilet

Caution:

• Gloves diminish sensitivity to heat
• Closely monitor heat level with infants, unresponsive or skin sensitive individuals

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

CardinalHealth antibacterial bathing wipes 8 Wipes (63517-200-21)

Label 200 A Label 200 B Label 200 C

CARDINALHEALTH ANTIBACTERIAL BATHING WIPES
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63517-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MYRISTAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: E4821CQM1I)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALLANTOIN (UNII: 344S277G0Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63517-200-21	139 g in 1 BAG; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	10/03/2013	03/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/03/2013	03/17/2020

Labeler - Cardinal Health 200, Inc. (961027315)

Name	Address	ID/FEI	Business Operations
Establishment
Yangzhou Perfect Daily Chemicals Co. Ltd		529256861	manufacture(63517-200)

Revised: 11/2022

Document Id: edb77a68-8a38-eebe-e053-2a95a90a2a29

Set id: 11d86c63-5695-460b-a97a-3e5907b69787

Version: 5

Effective Time: 20221117

Cardinal Health 200, Inc.