Label: SANIKIT- hand sanitizer gel gel
- NDC Code(s): 79067-004-01
- Packager: Renopac, S.A. de C.V.
- 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 12, 2023
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- ACTIVE INGREDIENT - OTC - ACTIVE INGREDIENT SECTION
- PURPOSE - OTC - PURPOSE SECTION
- USES - INDICATIONS AND USAGE SECTION
- WARNINGS - WARNINGS SECTIONS
- DO NOT USE - DO NOT USE SECTION
- WHEN USING THIS PRODUCT - WHEN USING SECTION
- STOP USE AND ASK A DOCTOR - STOP USE SECTION
- KEEP OUT OF REACH OF CHILDREN - KEEP OUT OF REACH OF CHILDREN SECTION
- DIRECTIONS - DOSAGE AND ADMINISTRATION SECTION
- OTHER INFORMATION - STORAGE AND HANDLING SECTION
- INACTIVE INGREDIENTS - INACTIVE INGREDIENT SECTION
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SANIKIT
hand sanitizer gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79067-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79067-004-01 5 mL in 1 POUCH; Type 0: Not a Combination Product 09/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/20/2023 Labeler - Renopac, S.A. de C.V. (811085489) Establishment Name Address ID/FEI Business Operations Renopac, S.A. de C.V. 811085489 manufacture(79067-004) , pack(79067-004) , label(79067-004)
SANIKIT 5g NDC - 79067-004-01