Label: BIOMIRACLE STAYSAFE HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77978-308-01 - Packager: MJM SOURCING, LLC
- 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 July 13, 2020
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INGREDIENTS AND APPEARANCE
BIOMIRACLE STAYSAFE HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77978-308 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 700 mL in 1000 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALOE VERA LEAF (UNII: ZY81Z83H0X) GRAPEFRUIT (UNII: O82C39RR8C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77978-308-01 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/13/2020 Labeler - MJM SOURCING, LLC (078861054) Establishment Name Address ID/FEI Business Operations WHITE COSPHARM CO.,LTD. 688442259 manufacture(77978-308)