PURPLE K- hypochlorous acid spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)
Available from:
PurpleK Co.,ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antimicrobial Hand Sanitizer to help reduce bacteria and viruses that potentially can cause disease. For use when soap and water are not available.
Authorization status:
unapproved drug other
Authorization number:
81185-010-01, 81185-010-02

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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.

Us es

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)

PURPLE K

hypochlorous acid spray

PurpleK Co.,ltd.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 118 5-0 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYPO CHLO RO US ACID (UNII: 712K4CDC10 ) (HYPOCHLOROUS ACID -

UNII:712K4CDC10 )

HYPOCHLOROUS

ACID

0 .0 0 3 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 118 5-0 10 -

120 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/27/20 20

2

NDC:8 118 5-0 10 -

50 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/27/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

11/27/20 20

Labeler -

PurpleK Co.,ltd. (694844712)

Registrant -

PurpleK Co.,ltd. (694844712)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

PurpleK Co .,ltd.

6 9 48 44712

ma nufa c ture (8 118 5-0 10 )

Revised: 12/2020

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