Label: SANICOP- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77208-001-01, 77208-001-02, 77208-001-03, 77208-001-04, view more77208-001-05, 77208-001-06, 77208-001-07, 77208-001-09, 77208-001-10 - Packager: vinicop 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 May 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SANICOP
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77208-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 67 mL in 100 mL Inactive Ingredients Ingredient Name Strength POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77208-001-01 1000000 mL in 1 TANK; Type 0: Not a Combination Product 03/01/2020 2 NDC:77208-001-02 200000 mL in 1 DRUM; Type 0: Not a Combination Product 03/01/2020 3 NDC:77208-001-03 19000 mL in 1 PAIL; Type 0: Not a Combination Product 03/01/2020 4 NDC:77208-001-04 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2020 5 NDC:77208-001-05 1000 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 03/01/2020 6 NDC:77208-001-06 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2020 7 NDC:77208-001-07 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2020 8 NDC:77208-001-09 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2020 9 NDC:77208-001-10 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/01/2020 Labeler - vinicop s.a. de c.v. (812841093) Establishment Name Address ID/FEI Business Operations vinicop s.a. de c.v. 812841093 manufacture(77208-001)