Label: 1012 ANTIMICROBIAL - chloroxylenol soap
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NDC Code(s):
62257-012-06,
62257-012-10,
62257-012-11,
62257-012-14,
view more62257-012-17, 62257-012-55
- Packager: ABC Compounding Co., Inc.
- 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 December 26, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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) CloseEstablishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(62257-012)
