Label: K OXIDERM OP POST PROCEDURE SKIN CARE BRUISE- magnesium ascorbyl phosphate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71588-0011-1 - Packager: EZEKIELCOSMETIC 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 August 25, 2017
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
for 4~5 days before cosmetic application, apply thinly twice a day, morning and night, after cleansing the skin
apply K oxiderm OP cream right after cosmetic application
K oxiderm OP cream is recommended for 10 to 15 days as preparatory skin care before and after surgical and medical cosmetic procedure
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WARNINGS
1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight4. Use as avoiding eye areas.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
K OXIDERM OP POST PROCEDURE SKIN CARE BRUISE
magnesium ascorbyl phosphate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71588-0011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) (ASCORBIC ACID - UNII:PQ6CK8PD0R) MAGNESIUM ASCORBYL PHOSPHATE 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) MAGNESIUM PHOSPHIDE (UNII: Q846538H9E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71588-0011-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/17/2017 Labeler - EZEKIELCOSMETIC CO., LTD (689851966) Registrant - EZEKIELCOSMETIC CO., LTD (689851966) Establishment Name Address ID/FEI Business Operations EZEKIELCOSMETIC CO., LTD 689851966 label(71588-0011) , manufacture(71588-0011) , pack(71588-0011)