Label: KO-KING EPISODE ONE- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78488-0005-1 - Packager: JNJ COSTEC CO
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 24, 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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
1. Do not use this product on the following parts of body. Around eyes and ears, oral cavity, large area of the
parts of body, or wounded skins (It may cause irritations)
2. Stop using at once in case of the following symptoms, and seek medical advice. 1) When eczema, red spots,
itchiness, edema, and allergic reactions occur. 2)When skin irritations happen.
3. Other user reminders 1) For external use only(No oral intake). 2) Avoid contact with eyes, and in case contact
occurs, rinse it thoroughly with clean water and consult a doctor or pharmacist. 3) When you use it on a large skin
area or use it long-termly, please be aware that vapor is not absorbed. (If Ethanol vapor is largely and repeatedly
inhaled and absorbed, it may cause irritation to mucous membrane and headache might occur.) 4)When the product
is used on the same part of skin repeatedly, the skin may become rough due to skimming. 5) Do not use with sealed
gauze bandage, Gibbs bandage or pack, as irritations may occur. 6) Do not use this product while anus and vagina
steaming as irritations or chemical burns may occur. 7) Do not use for purposes other than specified. - DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KO-KING EPISODE ONE
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78488-0005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) WATER (UNII: 059QF0KO0R) CARBOMER 940 (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78488-0005-1 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/24/2020 Labeler - JNJ COSTEC CO (694586192) Registrant - JNJ COSTEC CO (694586192) Establishment Name Address ID/FEI Business Operations JNJ COSTEC CO 694586192 manufacture(78488-0005) , label(78488-0005)
