ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER - alcohol spray

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

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Active ingredient:
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)
Available from:
National Pen Co., LLC
INN (International Name):
Alcohol
Composition:
Alcohol 4.96 mL in 8 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
51087-272-08

ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER - alcohol spray

National Pen Co., LLC

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.

----------

ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER

Label

ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER

USE: To decrease germs on the skin if water is not available. DIRECTIONS: Spray directly on skin.

Active Ingredient: Ethyl Alcohol (62%) Inactive Ingredients: Purified Water, Glycerin, Aloe Vera

Scent.

WARNINGS: For external use only. Do not use in or near the eyes. Keep out of the reach of children.

FLAMMABLE: Keep away from open flame. Size: 8ml/.25oz.

Contents made in USA. Packaging made in China. Distributed by National Pen Co., San Diego, 1-800-

854-1000 * www.pens.com

Active Ingredient:

Ethyl Alcohol (62%)

Inactive Ingredients:

Purified Water, Glycerin, Aloe Vera Scent

USE:

To decrease germs on the skin if water is not available.

DIRECTIONS:

Spray directly on skin.

Child Warning:

Keep out of the reach of children.

WARNINGS:

For external use only. Do not use in or near the eyes.

FLAMMABLE: Keep away from open flame.

Size:

8ml/.25oz.

ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER

alcohol spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:510 8 7-272

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Alco ho l (UNII: 3K9 9 58 V9 0 M) (Alco ho l - UNII:3K9 9 58 V9 0 M)

Alc o ho l

4.9 6 mL in 8 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Glycerin (UNII: PDC6 A3C0 OX)

Wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:510 8 7-272-0 8

8 mL in 1 BOTTLE, SPRAY

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 2/0 3/20 11

Labeler -

National Pen Co., LLC (809293140)

Registrant -

National Pen Co., LLC - San Diego, CA (807081638)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Natio nal Pen Co ., LLC

8 0 9 29 3140

pack, label

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Natio nal Design LLC

36 0 76 3320

re la be l

Establishment

National Pen Co., LLC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Atlas Pen & Pencil Co rp

8 76 6 16 0 25

re la be l

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Cro wn Labo rato ries

0 79 0 359 45

ma nufa c ture

Revised: 2/2011

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