Label: PURO MEDI- hypochlorous acid liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 81128-0001-1, 81128-0001-2 - Packager: The Garnet Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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 November 22, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and ears, in the oral cavity (may have irritating effects)
2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms - DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PURO MEDI
hypochlorous acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81128-0001 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:81128-0001-1 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2020 2 NDC:81128-0001-2 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/22/2020 Labeler - The Garnet Co., Ltd. (694625694) Registrant - The Garnet Co., Ltd. (694625694) Establishment Name Address ID/FEI Business Operations The Garnet Co., Ltd. 694625694 manufacture(81128-0001)