PURESAN OCEAN BREEZE- alcohol gel

Puresan by

Drug Labeling and Warnings

Puresan by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

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.

Uses

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 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, 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

INGREDIENTS AND APPEARANCE

PURESAN  OCEAN BREEZE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	42 mL  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
PERFLUOROALKYLETHYL ACRYLATES (C6-C14) (UNII: TKA54G588X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-141-01	1080 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-141-02	17280 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2018

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-141)