PURESAN HAND SANTIZING GEL- 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 Ingedient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Children reach

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

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.

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

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 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, 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

INGREDIENTS AND APPEARANCE

PURESAN  HAND SANTIZING GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
PERFLUOROALKYLETHYL ACRYLATES (C6-C14) (UNII: TKA54G588X)
ALOE (UNII: V5VD430YW9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-135-01	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2018	02/01/2020
2	NDC: 58575-135-02	8000 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018
3	NDC: 58575-135-03	1000 mL in 1 POUCH; 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(58575-135)