Label: MEDIKOII BIO SAFE HAND REFRESHING- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72695-0014-1 - Packager: THERANOTICS CO.,LTD.
- 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 June 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
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INACTIVE INGREDIENTS
Water, Ecklonia Cava Extract, Sophora Flavescens Extract, Centaurea Cyanus Flower Extract, Borago Officinalis Extract, Lavandula Angustifolia (Lavender) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis (Hyacinth) Extract, Carbomer, Butylene Glycol, Tromethamine, 1,2-Hexanediol, Fragrance
- PURPOSE
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WARNINGS
For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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
- Uses
- Directions
- Other information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEDIKOII BIO SAFE HAND REFRESHING
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72695-0014 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 Water (UNII: 059QF0KO0R) ECKLONIA CAVA (UNII: UXX2N5V39P) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) CENTAUREA CYANUS FLOWER (UNII: QZ239038YC) BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) CHAMOMILE (UNII: FGL3685T2X) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Butylene Glycol (UNII: 3XUS85K0RA) TROLAMINE (UNII: 9O3K93S3TK) 1,2-Hexanediol (UNII: TR046Y3K1G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72695-0014-1 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/01/2020 Labeler - THERANOTICS CO.,LTD. (694963085) Registrant - THERANOTICS CO.,LTD. (694963085) Establishment Name Address ID/FEI Business Operations BIO-FD&C. Co., Ltd. 688203268 manufacture(72695-0014)
