Radiance: Package Insert and Label Information

RADIANCE- 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.

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Active
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Purpose
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Indications
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RADIANCE
pcmx hand soap soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70542-307
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
SODIUM CHLORIDE
TRIMETHYLENEDIAMINETETRAACETIC ACID
SODIUM C14-16 OLEFIN SULFONATE
SODIUM LAURETH SULFATE
GLYCERIN
SODIUM SULFATE
GLYCOL STEARATE
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE
Product Characteristics
Color white (Melon odor) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70542-307-41 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 02/01/2017
Labeler — Midlab Incorporated (047371463)
Registrant — Midlab Incorporated (047371463)
Establishment
Name Address ID/FEI Operations
Midlab Incorporated 047371463 manufacture (70542-307)

Revised: 08/2018 Midlab Incorporated

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