PURPLE K- hypochlorous acid spray 
PurpleK Co.,ltd.

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

HYPOCHLOROUS ACID 0.003%

INACTIVE INGREDIENT

Water

PURPOSE

Antimicrobial

WARNINGS

For external use only.
Do not use
- for children 6 years and bolow
- on open skin wounds
- if pregnant or breast-feeding, comsult with your physician prior to 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.

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.

Uses

Hand Sanitizer to help reduce bacteria and viruses that potentially can cause disease. For use when soap and water are not available.

Directions

1. Turn the spray cap to ON
2. Spray 3-5 times at a 20cm distance from the targeted area
3. Dry well after spraying
4. Turn the spray cap OFF after use.

Other Information

Do not adulterate or dilute. Best when stored at room temperature, below 25 degrees Celsius. Keep away from direct sunlight and heat.
Do not freeze.
Disposal & Handling: This solution is biodegradable and environmentally safe. No special disposal considerations or handling precautions required.
Shelf life: 1 year from the date of manufacture

Package Label - Purple K 120mL
(NDC: 81185-010-01)

Image of bottle

Package Label - Purple K 500mL
(NDC: 81185-010-02)

Image of bottle

PURPLE K 
hypochlorous acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81185-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.003 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81185-010-01120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/27/2020
2NDC:81185-010-02500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/27/2020
Labeler - PurpleK Co.,ltd. (694844712)
Registrant - PurpleK Co.,ltd. (694844712)
Establishment
NameAddressID/FEIBusiness Operations
PurpleK Co.,ltd.694844712manufacture(81185-010)

Revised: 12/2020
Document Id: 08321a3c-8a1b-4c28-85a2-30289ec0ecf5
Set id: 9781c964-9924-4389-b134-5f687d262d06
Version: 2
Effective Time: 20201201
 
PurpleK Co.,ltd.