SAC-VAL PREMIUM CLEAR ANTISEPTIC HAND WASH- chloroxylenol soap
Sac Val Janitorial Sales & Service, 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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SAC-VAL Premium Clear Antiseptic Hand Wash

Active Ingredient

Chloroxylenol 0.4%

Purpose

Antiseptic

Uses

Handwash to help decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only.

When using this product

do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.

Stop use and ask a 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

Wet hands
Apply a small amount of product and work into a lather
Rinse well and dry hands completely

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamide DEA, Sodium Lauryl Sulfate, Propylene Glycol, Glycol Stearate, Tetrasodium EDTA, Salt, Citric Acid, Fragrance, Methylchloro isothiazolinone, Methyl isothiazolinone, Magnesium chloride, Magnesium nitrate, FDandC Yellow5

SAC-VAL Premium Clear Antiseptic Hand Wash 3780ml (42766-001-01)

premiumclear

SAC-VAL PREMIUM CLEAR ANTISEPTIC HAND WASH
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42766-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCOL STEARATE (UNII: 0324G66D0E)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42766-001-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/17/2012	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/17/2012	12/31/2019

Labeler - Sac Val Janitorial Sales & Service, Inc. (082793472)

Revised: 11/2019

Document Id: 9768e88d-ba4b-4f58-e053-2995a90a7346

Set id: 95dfa321-6f05-4b08-b151-780a2ce4b628

Version: 7

Effective Time: 20191115

Sac Val Janitorial Sales & Service, Inc.