Waxie Clear Tone by MIDLAB INCORPORATED

Waxie Clear Tone by

Drug Labeling and Warnings

Waxie Clear Tone by is a Otc medication manufactured, distributed, or labeled by MIDLAB INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WAXIE CLEAR TONE- pcmx, hand soap 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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Principal Display

Active Ingredient

PCMX 0.1%.

Purpose

Antiseptic Handwashing

Uses

• Handwash to help decrease bacteria on the skin.

Warning:

For external use only
Do not use in the eyes. In case of contact, flush thoroughly with water.

Stop use and ask doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison
Control Center right away.

Directions

Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse
Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Laureth-3 Sulfate, Sodium Chloride, Propylene glycol, Propanediol, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5, and Red 40.

WAXIE CLEAR TONE 
pcmx, hand soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70542-709
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
PROPANEDIOL (UNII: 5965N8W85T)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CINNAMALDEHYDE (UNII: SR60A3XG0F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
EUGENOL (UNII: 3T8H1794QW)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

Product Characteristics
Color	orange (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70542-709-41	3.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/21/2020	07/12/2021

Labeler - MIDLAB INCORPORATED (047371463)

Registrant - MIDLAB INCORPORATED (047371463)

Establishment
Name	Address	ID/FEI	Business Operations
MIDLAB INCORPORATED		047371463	manufacture(70542-709)

Revised: 7/2021

Document Id: c6ee116c-1544-ad1e-e053-2995a90a1acd

34390-5

Set id: ad650c8a-e9fd-ab1a-e053-2a95a90a705d

Version: 4

Effective Time: 20210712