Label: PURPLE K- hypochlorous acid spray
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Contains inactivated NDC Code(s)
NDC Code(s): 81185-010-01, 81185-010-02 - Packager: PurpleK Co.,ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated December 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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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
- Uses
- Directions
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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)
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INGREDIENTS AND APPEARANCE
PURPLE K
hypochlorous acid sprayProduct 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)
