PURESAN OCEAN BREEZE- 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:
58575-141-01, 58575-141-02

PURESAN OCEAN BREEZE- 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.

----------

Puresan Ocean Breeze Hand sanitizer 141

Active ingredient

Ethyl Alcohol 70% v/v

Purpos e

Antiseptic

Keep away from children

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.

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.

other information

May discolor certain fabrics and surfaces.

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 ingredients

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

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

Water

Puresan Ocean Breeze front label

puresan

Cleaning innovations

Kills 99.9% Ocean Breeze Scented

of germs Hand

Sanitizer

√ Ultimate protection

√ Ultra moisturizing

√ Leaves hands feeling ultra soft

Net. Wt. 18 fl. Oz.

puresan ocean breeze back label

AVRO-307DF Rev. 1.1

Drug Facts

Active Ingredient Purpose

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

Uses: To decrease bacteria on the skin that potentially can cause disease. Recommended for repeated

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, FD&C Blue 1, FD&C

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

Water

NOT TESTED ON ANIMALS

Got a question?

1-855-500-8080 puresan Puresan USA

puresanusa.com cleaning innovations Sparta, NJ 07871

Case label

puresan puresanusa.com

cleaning innovations (855) 500-8080

ITEM # 307

PURESAN Instant Hand Sanitizer Gel

18oz pump bottles OB case of 16 bottles BAR CODE

QTY 16 37654 23425

Bottles

AVRO-307-CS Rev: 1.0

PURESAN OCEAN BREEZE

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 575-141

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

42 mL in 6 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

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)

PEG/PPG-18 /18 DIMETHICO NE (UNII: 9 H0 AO7T79 4)

WATER (UNII: 0 59 QF0 KO0 R)

Inopak, Ltd

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:58 575-141-

10 8 0 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/20 18

2

NDC:58 575-141-

1728 0 mL in 1 CASE; 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 (58 575-141)

Revised: 2/2020

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