MONK HAND SANITIZING WIPES- benzethonium chloride cloth

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

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Active ingredient:
Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP)
Available from:
National Towelette Company
INN (International Name):
Benzethonium Chloride
Composition:
Benzethonium Chloride 30 mL in 1000 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Antibacterial - over large areas - If you are allergic to any of the ingredients Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours
Authorization status:
OTC monograph not final
Authorization number:
50320-111-58

MONK HAND SANITIZING WIPES- benzethonium chloride cloth

National Towelette Company

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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Active Ingredients:

Benzethonium Chloride (0.3%)

Purpose:

Antibacterial

Use decreases bacteria on skin

Warnings For external use only

Do not use

over large areas

If you are allergic to any of the ingredients

When using this product

do not get into eyes

If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right

away.

Directions: Adults and children 2 years and over: apply on hands and face to clean and refresh. Allow

skin to dry without wiping. Children under 2 years: as a doctor before use. For Children under 6 use

only under supervision.

Inactive Ingredients: Water, SD Alcohol 40-B, Sodium Benzoate, Diazolidinyl Urea, Glycerin,

Propylene Glycol, Potassium Sorbate, Disodium EDTA, Tocopheryl Acetate, Aloe

Store under 110 F

Questions and Comments: For products or technical information, contact National Towelette Monday to

Friday 8 AM to 4 PM EST at 1-800-738-9068, or visit our website at www.towelettes.com

MONK HAND SANITIZING WIPES

benzethonium chloride cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 320 -111

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Benzetho nium Chlo ride (UNII: PH41D0 5744) (Benzetho nium - UNII:1VU15B70 BP)

Benzetho nium Chlo ride

30 mL in 10 0 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

8 79 mL in 10 0 0 mL

Etha no l (UNII: 3K9 9 58 V9 0 M)

111.6 0 mL in 10 0 0 mL

So dium Benzo a te (UNII: OJ245FE5EU)

1.30 mL in 10 0 0 mL

Dia zo lidinylurea (UNII: H5RIZ3MPW4)

1.30 mL in 10 0 0 mL

Glycerin (UNII: PDC6 A3C0 OX)

1.0 0 mL in 10 0 0 mL

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

1.0 0 mL in 10 0 0 mL

Po ta ssium So rba te (UNII: 1VPU26 JZZ4)

.75 mL in 10 0 0 mL

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

.45 mL in 10 0 0 mL

Alpha -To co phero l Aceta te (UNII: 9 E8 X8 0 D2L0 )

0 .10 mL in 10 0 0 mL

Alo e (UNII: V5VD430 YW9 )

0 .0 9 mL in 10 0 0 mL

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 320 -111-58

50 0 mL in 1 CANISTER

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 rt333

0 1/0 6 /20 10

National Towelette Company

Labeler -

National T owelette Company (782795041)

Registrant -

National T owelette Company (782795041)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Natio nal To welette Co mpany

78 279 50 41

re pa c k

Revised: 1/2010

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