Label: SERVO-STAT P ANTISEPTIC HAND WASH- chloroxylenol liquid
- NDC Code(s): 76378-021-01, 76378-021-02, 76378-021-03, 76378-021-04
- Packager: Enzyme Solutions, 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 14, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SERVO-STAT P ANTISEPTIC HAND WASH
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76378-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.6 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) EDETATE SODIUM (UNII: MP1J8420LU) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) BORIC ACID (UNII: R57ZHV85D4) PEG-75 LANOLIN (UNII: 09179OX7TB) DMDM HYDANTOIN (UNII: BYR0546TOW) ALOE VERA LEAF (UNII: ZY81Z83H0X) 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:76378-021-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2018 2 NDC:76378-021-02 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2018 3 NDC:76378-021-03 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2018 4 NDC:76378-021-04 1000 mL in 1 BAG; Type 0: Not a Combination Product 12/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/14/2018 Labeler - Enzyme Solutions, Inc. (004994559) Establishment Name Address ID/FEI Business Operations Enzyme Solutions, Inc. 004994559 manufacture(76378-021)