Label: OPI ANTISEPTIC FOAMING HAND CLEANER- chloroxylenol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 43196-510-05 - Packager: OPI Correctional Industries
- 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 March 7, 2011
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- SPL UNCLASSIFIED SECTION
- Active Ingredient:
- Purpose:
- Uses
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Warnings
- For external use only
- Keep out of reach of children.
- In case of eye contact flush with water for 15 minutes, if irritation persists, get medical attention.
- In case of accidental ingestion, seek medical attention or contact a poison control center immediately.
- This product must be dispensed from an adequate dispenser located a sufficient distance from processing line to prevent accidental product contamination.
- Do not contaminate water, food or feed by storage and disposal.
- Directions
- Inactive Ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
OPI ANTISEPTIC FOAMING HAND CLEANER
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43196-510 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol 15.75 g in 1000 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) sodium laureth sulfate (UNII: BPV390UAP0) cocamidopropyl betaine (UNII: 5OCF3O11KX) hydroxyethyl cellulose (2000 CPS at 1%) (UNII: S38J6RZN16) isopropyl alcohol (UNII: ND2M416302) coco diethanolamide (UNII: 92005F972D) triclosan (UNII: 4NM5039Y5X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43196-510-05 3785 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/07/2011 Labeler - OPI Correctional Industries (809174501) Establishment Name Address ID/FEI Business Operations Canberra Corporation 068080621 MANUFACTURE