Smart Foaming Antibacterial: Package Insert and Label Information

SMART FOAMING ANTIBACTERIAL- chloroxylenol soap
Midlab Incorporated

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.

Principal
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Active Ingredient

Active ingredient
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Purpose

Purpose
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indications and usage

Indications and usage
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Warnings

Warnings
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Ask a doctor

Ask doctor
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KOOROC

KOOROC
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Dosage and Admin

Dosage
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Inactive Ingredients

Inactive ingredients
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SMART FOAMING ANTIBACTERIAL
pcmx, hand soap soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70542-603
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 0.1 g in 1 L
Inactive Ingredients
Ingredient Name Strength
LAURAMINE OXIDE
SODIUM LAURETH SULFATE
FD&C RED NO. 40
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE
FD&C YELLOW NO. 5
Product Characteristics
Color orange Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70542-603-41 3.78 L in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/31/2019
Labeler — Midlab Incorporated (047371463)
Registrant — Midlab Incorporated (047371463)
Establishment
Name Address ID/FEI Operations
Midlab Incorporated 047371463 manufacture (70542-603)

Revised: 06/2019 Midlab Incorporated

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