ANTIMICROBIAL- body cleanser liquid

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

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
McKesson
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antiseptic Uses a no-rinse topical antiseptic for reducing and inhibiting bacterial growth. Stop use and ask a doctor if - irritation and redness develop - condition persists for more than 72 hours
Authorization status:
OTC monograph not final
Authorization number:
68599-0214-4, 68599-0214-8

ANTIMICROBIAL- body cleanser liquid

McKes s on

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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Antimicrobial Body Cleanser

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

a no-rinse topical antiseptic for reducing and inhibiting bacterial growth.

Warnings

For external use only.

When using this product

do not get into eyes

Do not use on

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

irritation and redness develop

condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions

Spray soiled and/or odorous (body and/or perineal) areas

Gently wipe clean

Repeat as necessary until all soils are removed and skin is clean

Pat dry

No rinsing necessary

Apply a protectant cream or paste as necessary

Store at 40-95ºF (4-35ºC)

Inactive Ingredients:

Purified Water, Butylene Glycol, Glycerin, Polysorbate 20, Aloe Barbadensis Leaf Juice,

Sodium Hyaluronate, Carthamus Tinctorius (Safflower) Oleosomes, Phenoxyethanol, Caprylyl Glycol,

Chlorphenesin, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3),

Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C),

Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Fragrance, Tetrasodium EDTA,

Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline,

Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine,

(may contain Sodium Hydroxide, Citric Acid)

Questions?

Call 1-800-777-4908

NDC 68599-0214-4

McKesson

Thera

ANTIMICROBIAL BODY CLEANSER

A no-rinse topical cleanser for reducing and inhibiting bacterial growth.

Single Patient Use

NET CONTENTS 4 fl. oz (118 mL)

MFR # 53-AC4

NDC 68599-0214-8

McKesson

Thera

ANTIMICROBIAL BODY CLEANSER

A no-rinse topical cleanser for reducing and inhibiting bacterial growth.

Single Patient Use

NET CONTENTS 8 fl. oz (237 mL)

MFR # 53-AC8

ANTIMICROBIAL

body cleanser liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 59 9 -0 214

Route of Administration

TOPICAL

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 ug

in 1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

PHENYLALANINE (UNII: 47E5O17Y3R)

ARGININE (UNII: 9 4ZLA3W45F)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

SO DIUM ASCO RBYL PHO SPHATE (UNII: 8 36 SJG51DR)

O CTENYLSUCCINIC ACID (UNII: 12UZE4X73L)

THREO NINE (UNII: 2ZD0 0 419 0 S)

GLYCINE (UNII: TE76 6 0 XO1C)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

HISTIDINE (UNII: 4QD39 79 8 7E)

ISO LEUCINE (UNII: 0 4Y759 0 D77)

CARTHAMUS TINCTO RIUS ( SAFFLO WER) O LEO SO MES (UNII: 9 S6 0 Q7230 9 )

CALCIUM PANTO THENATE (UNII: 56 8 ET8 0 C3D)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

PYRIDO XINE HYDRO CHLO RIDE (UNII: 6 8 Y4CF58 BV)

McKesson

ASPARTIC ACID (UNII: 30 KYC7MIAI)

GLUTAMIC ACID (UNII: 3KX376 GY7L)

ALANINE (UNII: OF5P57N2ZX)

TYRO SINE (UNII: 42HK56 0 48 U)

SERINE (UNII: 452VLY9 40 2)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CYSTEINE (UNII: K8 48 JZ48 8 6 )

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

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

WATER (UNII: 0 59 QF0 KO0 R)

PRO LINE (UNII: 9 DLQ4CIU6 V)

VALINE (UNII: HG18 B9 YRS7)

LEUCINE (UNII: GMW6 7QNF9 C)

NIACINAMIDE (UNII: 25X51I8 RD4)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

LYSINE (UNII: K3Z4F9 29 H6 )

METHIO NINE (UNII: AE28 F7PNPL)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 59 9 -0 214-4

118 mg in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /12/20 19

2

NDC:6 8 59 9 -0 214-8

237 mg in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /12/20 19

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 rt333E

0 8 /12/20 19

Labeler -

McKesson (023904428)

Revised: 1/2020

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