Waxie antibacterial by Midlab, Inc

Waxie antibacterial by

Drug Labeling and Warnings

Waxie antibacterial by is a Otc medication manufactured, distributed, or labeled by Midlab, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WAXIE ANTIBACTERIAL- pcmx, hand soap soap 
Midlab, Inc

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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Principal Display

Active Ingredient Section

Purpose

Uses

Warnings

Ask Doctor

KOOROC

Dosage and Admin

Inactive Ingredients

WAXIE ANTIBACTERIAL 
pcmx, hand soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70542-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	2.5 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
GLYCOL STEARATE (UNII: 0324G66D0E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)
TRIMETHYLENEDIAMINETETRAACETIC ACID (UNII: 3F6OA94EER)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
RHODAMINE B (UNII: K7G5SCF8IL)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)

Product Characteristics
Color	pink (Pearly)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70542-902-23	0.53 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/24/2020	07/16/2020
2	NDC: 70542-902-41	3.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/25/2020
3	NDC: 70542-902-24	0.47 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/24/2020	12/02/2021

Labeler - Midlab, Inc (047371463)

Registrant - Midlab, Inc (047371463)

Establishment
Name	Address	ID/FEI	Business Operations
Midlab, Inc		047371463	manufacture(70542-902)

Revised: 12/2021

Document Id: d22e5699-1f34-4439-e053-2995a90ab00e

34390-5

Set id: a8d99c43-5a4f-6b8f-e053-2995a90a4a10

Version: 4

Effective Time: 20211202