Label: ANTIBACTERIAL LIQUID HAND- parachlorometaxylenol liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 50241-020-01 - Packager: Morgan Gallacher Inc. DBA Custom Chemical Formulators 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 November 12, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Antibacterial Liquid Hand Soap
ACTIVE INGREDIENT
Parachlorometaxylenol 0.3%
Purpose
Antibacterial
USES
For hand washing to decrease bacteria on the skin
Warnings For external Use only
When Using this Product- Avoid contact with the eyes.
In case of eye contact, fluch eyes with water.
Stop use and ask a doctor if irritation or redness develops
or if condition persist for more than 72 hours.
-
INGREDIENTS AND APPEARANCE
ANTIBACTERIAL LIQUID HAND
parachlorometaxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50241-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength chloroxylenol (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) chloroxylenol 0.30 kg in 100 kg Inactive Ingredients Ingredient Name Strength SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) HYDANTOIN (UNII: I6208298TA) GLYCERIN (UNII: PDC6A3C0OX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50241-020-01 3.91 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/12/2015 Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595) Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595) Establishment Name Address ID/FEI Business Operations Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. 028311595 manufacture(50241-020) , api manufacture(50241-020) , pack(50241-020)