PURESAN HAND SANTIZING GEL- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Inopak. Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - To decrease bacteria on the skin that potentially can cause disease - Recommended for repeated use - Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.
Authorization status:
OTC monograph not final
Authorization number:
58575-135-01, 58575-135-02, 58575-135-03

PURESAN HAND SANTIZING GEL- alcohol gel

Inopak. Ltd

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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puresan Hand Sanitizing Gel 135

Active Ingedient

Ethyl Alcohol 70% v/v

Purpos e

Antiseptic

Children reach

Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

Us es

To decrease bacteria on the skin that potentially can cause disease

Recommended for repeated use

Warnings

Flammable, keep away from heat or flame.

For external use only.

Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation and redness develop or if 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. Children should be supervised by an adult when using this product.

Stop Use

Stop use and ask a doctor if irritation and redness develop or if condition persists for more than

72 hours.

Directions

Apply sufficient amount of product to your palm to cover both hands.

Rub until dry.

Inactive Ingredient

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, D&C Blue 1, FD&C

Yellow 5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18 Dimethicone, Triethanolamine, Vitamin E,

Water

puresan individual lable

Instant Waterless

Instant Waterless

Hand Kills 99.99% of Germs

Santizing Gel

With Aloe Vera & Vitamin E

1000 mL

Refill Bag GEL

Item# Hs1000 puresan

Cleaning innovations

MADE

IN THE USA

Drug Facts

Active Ingredient Purpose

Ethyl Alcohol 70% v/v …………….. Antiseptic

Us es

To decrease bacteria on the skin that

potentially can cause disease

Recommended for repeated use

Warnings

Flammable, keep away from heat or flame.

For external use only.

Keep out of eyes, ears or mouth. In case of

eye contact, flush eyes with water.

Stop use and ask a doctor if irritation and

redness develop or if 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. Children

should be supervised by an adult when using

this product.

Directions

Apply sufficient amount of product to your palm to

cover both hands.

Rub until dry.

Other Information

May discolor certain fabrics and surfaces.

Inactive Ingredients

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe

Barbadensis Leaf Juice, D&C Blue 1, FD&C Yellow

5, Fragrance, Isopropyl Alcohol, PEG/PPG-18/18

Dimethicone, Triethanolamine, Vitamin E, Water

Rev. 1.01

PO Box 170 Sparta NJ 077871

855.500.8080 puresanusa.com

puresan case label

puresan puresanusa.com

cleaning innovations (855) 800-8080

ITEM # HS1000GOB-D-C8

PURESAN 1000ml Instant Hand Sanitizer

Disc Refill pouch case of I

QTY 8

1000ml refills per case 94026 39611

PURESAN HAND SANTIZING GEL

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 575-135

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) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

70 mL in 10 0 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PERFLUO RO ALKYLETHYL ACRYLATES ( C6 -C14 ) (UNII: TKA54G58 8 X)

ALO E (UNII: V5VD430 YW9 )

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

TRIETHANO LAMINE 2 -CYCLO HEXYL-4 ,6 -DINITRO PHENO LATE (UNII: N2TK31JIAH)

wa ter (UNII: 0 59 QF0 KO0 R)

Inopak. Ltd

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 575-135-0 1

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 18

0 2/0 1/20 20

2

NDC:58 575-135-0 2

8 0 0 0 mL in 1 CASE; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 18

3

NDC:58 575-135-0 3

10 0 0 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 1/0 1/20 18

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 1/0 1/20 18

Labeler -

Inopak. Ltd (194718243)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ino pak. Ltd

19 4718 243

ma nufa c ture (58 575-135)

Revised: 2/2020

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