NDC | 62257-012-06, 62257-012-10, 62257-012-11, 62257-012-14, 62257-012-17, 62257-012-55 |
Set ID | 4dc6367c-5347-4a5c-b0d0-e93a4277a849 |
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
wet hands and forearms
apply 5 milliliters (teaspoonful) or palmful to hands and forearms
scrub thoroughly for 1 minute and rinse
Close - Drug Facts Box OTC-Inactive Ingredient Section
water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, DMD hydantoin, fragrance, FD and C yellow no.5, food red 10
Close - 1012 Antimicrobial 6544 1 gallon bottle
- INGREDIENTS AND APPEARANCE
1012 ANTIMICROBIAL
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62257-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) SODIUM CHLORIDE (UNII: 451W47IQ8X) DMDM HYDANTOIN (UNII: BYR0546TOW) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62257-012-06 1 in 1 BOX 05/01/2013 1 800 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:62257-012-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2013 3 NDC:62257-012-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 05/01/2013 4 NDC:62257-012-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2013 5 NDC:62257-012-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2013 6 NDC:62257-012-55 208200 mL in 1 DRUM; Type 0: Not a Combination Product 05/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2013 Labeler - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(62257-012)