HYPOCHLOROUS ACID- bactistop 500 liquid

Hypochlorous Acid by

Drug Labeling and Warnings

Hypochlorous Acid by is a Otc medication manufactured, distributed, or labeled by L'ENVOL PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Hypochlorous Acid 2% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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.

STOP USE

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

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 ingredients

water

Package Label - Principal Display Panel

500 mL NDC: 79394-501-01

INGREDIENTS AND APPEARANCE

HYPOCHLOROUS ACID 
bactistop 500 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79394-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79394-501-01	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2020

Labeler - L'ENVOL PHARMA (362865293)

Registrant - L'ENVOL PHARMA (362865293)

Establishment
Name	Address	ID/FEI	Business Operations
L'ENVOL PHARMA		362865293	manufacture(79394-501)