Label: PURISTIC- sodium chlorite liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 82422-001-01 - Packager: MEDI K 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 November 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warning
- When using this product
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Do not use
- in children less than 2 months of age
- on open skin wounds
■ Do not use the product for a long time in the same area as swelling, inflammation or sickness
may occur due to absorption through the skin.
It is not recommended to use this one area that have been medically treated with a cast or
bandage.
■ Do not use in combination with soap or antibacterial cleansing agents. -
ASK DOCTOR
■ Stop immediately and consult a doctor if you experience
1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
2) Skin Irritation
3) Following Instructions when using medication
(1) For external use only (Do not use internally)
(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)
■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.
■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.It is not recommended to use this one area that have been medically treated with a cast or
bandage. - KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
- Package Label
-
INGREDIENTS AND APPEARANCE
PURISTIC
sodium chlorite liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82422-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6) SODIUM CHLORITE 4.6 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82422-001-01 6 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/27/2021 Labeler - MEDI K Co., Ltd. (695158681) Registrant - MEDI K Co., Ltd. (695158681) Establishment Name Address ID/FEI Business Operations MEDI K Co., Ltd. 695158681 manufacture(82422-001)