PHOENIX HAND SANITIZER- isopropyl alcohol liquid

Phoenix Hand Sanitizer by

Drug Labeling and Warnings

Phoenix Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Phoenix Mcbs Llc, Shotwell Hydrogenics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient(s)

Isopropyl Alcohol 70% 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 for a doctor if irritation 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 15-30C(59-86F)
        Avoid freezing and excessive heat above 40C(104F)

INACTIVE INGREDIENT

Inactive ingredients glycerin, carbomer, deionized water, triethanolamine

SPL UNCLASSIFIED SECTION

Distributed By
Phoenix Protective Coatings
804 Summer Park Drive Ste. 450
Stafford, Texas 77477

Packaging

INGREDIENTS AND APPEARANCE

PHOENIX HAND SANITIZER 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75547-905
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75547-905-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2020
2	NDC: 75547-905-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2020
3	NDC: 75547-905-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2020
4	NDC: 75547-905-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2020
5	NDC: 75547-905-64	1893 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2020
6	NDC: 75547-905-10	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/17/2020

Labeler - Phoenix Mcbs Llc (087324458)

Establishment
Name	Address	ID/FEI	Business Operations
Shotwell Hydrogenics, LLC		108985732	manufacture(75547-905)