ENVIROMED HAND SANITIZER- benzalkonium chloride solution

Enviromed Hand Sanitizer by

Drug Labeling and Warnings

Enviromed Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Unysource Enterprise. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

Benzalkonium chloride 0.15%

Purpose

Antiseptic

Uses

For hand sanitizing. To decrease bacteria on the skin.

Warnings

For external use only.

Do not use in the eyes.

In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or redness develops, or if condition persists more than 72 hours.

Keep out of reach of children.

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply small amount to wetted hands and wash vigorously for 15 seconds, make sure to get between fingers and under finger nails. Rinse with warm, clean water. Repeat as necessary. 

Inactive Ingredients

Tea tree oil, Cocamidopropyl Betaine, Sweet Orange, Glycerin, Panthenol, Water

Purpose

Antiseptic

Uses

For hand sanitizing. To decrease bacteria on the skin.

Warnings

For external use only.

Do Not Use

In case of eye contact, rinse eyes thoroughly with water.

Stop Use Ask a Doctor

if irritation or redness develops, or if condition persists more than 72 hours.

Keep Out of Reach of Children

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply small amount to wetted hands and wash vigorously for 15 seconds, make sure to get between fingers and under finger nails. Rinse with warm, clean water. Repeat as necessary.

Inactive Ingredients

Tea tree oil, Cocamidopropyl Betaine, Sweet Orange, Glycerin, Panthenol, Water

Purpose

Antiseptic

Uses

For hand sanitizing. To decrease bacteria on the skin.

Warnings

For external use only.

Do Not Use

In case of eye contact, rinse eyes thoroughly with water.

Stop Use Ask a Doctor

if irritation or redness develops, or if condition persists more than 72 hours.

Keep Out of Reach of Children

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply small amount to wetted hands and wash vigorously for 15 seconds, make sure to get between fingers and under finger nails. Rinse with warm, clean water. Repeat as necessary.

Inactive Ingredients

Tea tree oil, Cocamidopropyl Betaine, Sweet Orange, Glycerin, Panthenol, Water

Purpose

Antiseptic

Uses

For hand sanitizing. To decrease bacteria on the skin.

Warnings

For external use only.

Do not Use

In case of eye contact, rinse eyes thoroughly with water.

Stop Use Ask a Doctor

if irritation or redness develops, or if condition persists more than 72 hours.

Keep Out of Reach of Children

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply small amount to wetted hands and wash vigorously for 15 seconds, make sure to get between fingers and under finger nails. Rinse with warm, clean water. Repeat as necessary.

Inactive Ingredients

Tea tree oil, Cocamidopropyl Betaine, Sweet Orange, Glycerin, Panthenol, Water

Purpose

Antiseptic

Uses

For hand sanitizing. To decrease bacteria on the skin.

Warnings

For External Use only

Do not Use

In case of eye contact, rinse eyes thoroughly with water.

Stop Use and Ask a Doctor

if irritation or redness develops, or if condition persists more than 72 hours.

Keep out of Reach of Children

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply small amount to wetted hands and wash vigorously for 15 seconds, make sure to get between fingers and under finger nails. Rinse with warm, clean water. Repeat as necessary.

Inactive Ingredients

Tea tree oil, Cocamidopropyl Betaine, Sweet Orange, Glycerin, Panthenol, Water

Purpose

Antiseptic

Uses

For hand sanitizing. To decrease bacteria on the skin.

Warnings

For external use only.

Do not Use

In case of eye contact, rinse eyes thoroughly with water.

Stop Use and Ask a Doctor

if irritation or redness develops, or if condition persists more than 72 hours.

Keep out of Reach of Children

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply small amount to wetted hands and wash vigorously for 15 seconds, make sure to get between fingers and under finger nails. Rinse with warm, clean water. Repeat as necessary.

Inactive Ingredients

Tea tree oil, Cocamidopropyl Betaine, Sweet Orange, Glycerin, Panthenol, Water

PRINCIPAL DISPLAY PANEL

20ml NDC: 79505-012-01

PRINCIPAL DISPLAY PANEL

60ml NDC: 79505-012-02

Principal Display Panel

250 ml NDC: 79505-012-03

Principal Display Panel

500 mL NDC: 79505-012-04

Principal Display Panel

1000ml NDC: 79505-012-05

Principal Display Panel

4000 mL NDC: 79505-012-06

INGREDIENTS AND APPEARANCE

ENVIROMED HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79505-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0015 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
ORANGE OIL (UNII: AKN3KSD11B)
PANTHENOL (UNII: WV9CM0O67Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79505-012-01	20 mL in 1 POUCH; Type 0: Not a Combination Product	07/30/2020
2	NDC: 79505-012-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/30/2020
3	NDC: 79505-012-03	250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/30/2020
4	NDC: 79505-012-04	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/30/2020
5	NDC: 79505-012-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
6	NDC: 79505-012-06	4000 mL in 1 JAR; Type 0: Not a Combination Product	07/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/30/2020

Labeler - Unysource Enterprise (204167139)

Establishment
Name	Address	ID/FEI	Business Operations
Unysource Enterprise		204167139	manufacture(79505-012)