OASIS ANTISEPTIC HAND RUB / HAND SANITIZER- isopropyl alcohol solution

OASIS Antiseptic Hand Rub / Hand Sanitizer by

Drug Labeling and Warnings

OASIS Antiseptic Hand Rub / Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by OASIS Medical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(s)

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water

SPL UNCLASSIFIED SECTION

Manufactured by: OASIS Medical, Inc.
510-528 S. Vermont Ave
Glendora, CA 91741 USA

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Oasis Antiseptic Hand Rub / Hand Sanitizer

Isopropyl Alcohol Antiseptic 75% Topical
Non-Sterile Solution (6 FL OZ / 177 mL)

Prepared under FDA guidance consistent with
World Health Organization Formulation

Manufactured by: OASIS Medical, Inc.
510-528 S. Vermont Ave
Glendora, CA 91741 USA

LOT Lot Number
YYYY-MM-DD

Product No: OH1000-6
NDC: 42126-1000-1

INGREDIENTS AND APPEARANCE

OASIS ANTISEPTIC HAND RUB / HAND SANITIZER 
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42126-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302)	Isopropyl Alcohol	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42126-1000-1	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
2	NDC: 42126-1000-2	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	04/01/2020

Labeler - OASIS Medical, Inc. (194121018)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS Medical, Inc.		194121018	MANUFACTURE(42126-1000)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS Medical, Inc.		024362989	PACK(42126-1000)