HAND SANITIZER- hypochlorous acid solution 
THAI WACOAL PUBLIC COMPANY LIMITED

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

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

Other information

Inactive ingredients

Water, Sodium Chloride, Seawater, Collodial Gold

Package Label - Principal Display Panel

50mL NDC:79841 -001-05

50 mL Spray

100 mL NDC:79841 -001-10

100 mL Spray

450 mL NDC:79841 -001-45

450 mL Spray

HAND SANITIZER 
hypochlorous acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79841-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID95 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GOLD (UNII: 79Y1949PYO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MERCURY (UNII: FXS1BY2PGL)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79841-001-0550 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2020
2NDC:79841-001-10100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2020
3NDC:79841-001-45450 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/31/2020
Labeler - THAI WACOAL PUBLIC COMPANY LIMITED (659934301)
Establishment
NameAddressID/FEIBusiness Operations
IREAL PLUS (THAILAND) COMPANY LIMITED671902247manufacture(79841-001)

Revised: 7/2020
Document Id: abbf5ce9-e4af-106e-e053-2a95a90a0d0c
Set id: abbfbe65-f783-ea55-e053-2995a90aa002
Version: 1
Effective Time: 20200731
 
THAI WACOAL PUBLIC COMPANY LIMITED