Label: SOFTEN SURE FOAM ANTIMICROBIAL- chloroxylenol liquid
- NDC Code(s): 59900-211-06, 59900-211-10, 59900-211-11
- Packager: Best Sanitizers, 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 January 4, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When Using this product
- Keep out of reach of children
- Directions
- Other Information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SOFTEN SURE FOAM ANTIMICROBIAL
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59900-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 10 g in 1000 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POTASSIUM COCOATE (UNII: F8U72V8ZXP) EDETATE SODIUM (UNII: MP1J8420LU) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59900-211-06 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2008 2 NDC:59900-211-10 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2008 3 NDC:59900-211-11 1000 mL in 1 BAG; Type 0: Not a Combination Product 09/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/01/2008 Labeler - Best Sanitizers, Inc (957473614) Establishment Name Address ID/FEI Business Operations Best Sanitizers, Inc 627278224 manufacture(59900-211)