PURPLE K- hypochlorous acid spray

Purple K by

Drug Labeling and Warnings

Purple K by is a Otc medication manufactured, distributed, or labeled by PurpleK Co.,ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

Package Label - Purple K 500mL(NDC:

81185-010-02)

INGREDIENTS AND APPEARANCE

PURPLE K 
hypochlorous acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81185-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.003 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81185-010-01	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/27/2020
2	NDC: 81185-010-02	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/27/2020

Labeler - PurpleK Co.,ltd. (694844712)

Registrant - PurpleK Co.,ltd. (694844712)

Establishment
Name	Address	ID/FEI	Business Operations
PurpleK Co.,ltd.		694844712	manufacture(81185-010)