ANTIBACTERIAL BATHING- benzalkonium chloride cloth

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Cardinal Health, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- to decrease bacteria on skin
Authorization status:
OTC monograph not final
Authorization number:
63517-210-22

ANTIBACTERIAL BATHING- benzalkonium chloride cloth

Cardinal Health, 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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Antibacterial Bathing Wipe

Drug Facts

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:

ANTIBACTERIAL BATHING

benzalkonium chloride cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 3517-210

Route of Administration

TOPICAL

Cardinal Health, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.3 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

MYRISTAMIDO PRO PYL PRO PYLENE GLYCO L-DIMO NIUM CHLO RIDE PHO SPHATE (UNII: E48 21CQM1I)

LINO LEAMIDO PRO PYL PRO PYLENE GLYCO L-DIMO NIUM CHLO RIDE PHO SPHATE (UNII: 5Q8 7K46 1JO)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

ALLANTO IN (UNII: 344S277G0 Z)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 3517-210 -22

8 in 1 PACKET

0 5/15/20 19

1

1 in 1 POUCH

1

13.775 mL in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 5/15/20 19

Labeler -

Cardinal Health, Inc. (097537435)

Revised: 5/2019

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