HAND SANITIZER- hypochlorous acid solution

Hand sanitizer by

Drug Labeling and Warnings

Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by THAI WACOAL PUBLIC COMPANY LIMITED, IREAL PLUS (THAILAND) COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Hypochlorous Acid 95% v/v.

Purpose

Purpose: Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

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

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, Sodium Chloride, Seawater, Collodial Gold

Package Label - Principal Display Panel

50mL NDC:79841 -001-05

100 mL NDC:79841 -001-10

450 mL NDC:79841 -001-45

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hypochlorous acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79841-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	95 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GOLD (UNII: 79Y1949PYO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MERCURY (UNII: FXS1BY2PGL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79841-001-05	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/31/2020
2	NDC: 79841-001-10	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/31/2020
3	NDC: 79841-001-45	450 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/31/2020

Labeler - THAI WACOAL PUBLIC COMPANY LIMITED (659934301)

Establishment
Name	Address	ID/FEI	Business Operations
IREAL PLUS (THAILAND) COMPANY LIMITED		671902247	manufacture(79841-001)