NDC | 62257-855-01, 62257-855-03, 62257-855-05, 62257-855-07, 62257-855-09, 62257-855-10, 62257-855-11, 62257-855-12, 62257-855-13, 62257-855-14, 62257-855-15, 62257-855-16, 62257-855-17, 62257-855-18, 62257-855-24, 62257-855-27, 62257-855-28, 62257-855-55 |
Set ID | fbce9c17-8fb2-4461-92e4-f888a299b1a9 |
Category | HUMAN OTC DRUG LABEL |
Packager | ABC Compounding Co., Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333E |
- Drug Facts Box OTC-Active Ingredient Section
- Drug Facts Box OTC-Purpose Section
- Drug Facts Box OTC-Indications & Usage Section
- Drug Facts Box OTC-Warnings Section
- Drug Facts Box OTC-When Using Section
- Drug Facts Box OTC-Stop Use Section
- Drug Facts Box OTC-Keep Out of Reach of Children Section
- Drug Facts Box OTC-Dosage & Administration Section
- Drug Facts Box OTC-Inactive Ingredient Section
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INGREDIENTS AND APPEARANCE
FAST
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62257-855 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62257-855-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2019 2 NDC:62257-855-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 07/08/2019 3 NDC:62257-855-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2019 4 NDC:62257-855-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 07/08/2019 5 NDC:62257-855-08 1 in 1 BOX 07/08/2019 5 1000 mL in 1 BAG; Type 0: Not a Combination Product 6 NDC:62257-855-18 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/08/2019 Labeler - ABC Compounding Co., Inc. (003284353) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(62257-855)