FRESHANDS PREMIUM FOAMY ANTIBACTERIAL HANDSOAP 6876- chloroxylenol soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)

Available from:

Consolidated Chemicals, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic for hand-washing to decrease bacteria on the skin irritation and redness develop

Authorization status:

OTC monograph not final

Summary of Product characteristics

FRESHANDS PREMIUM FOAMY ANTIBACTERIAL HANDSOAP 6876-
CHLOROXYLENOL SOAP
CONSOLIDATED CHEMICALS, LLC
_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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FRESHANDS PREMIUM FOAMY ANTIBACTERIAL HANDSOAP 6876
DRUG FACTS BOX OTC-ACTIVE INGREDIENT SECTION
Chloroxylenol 0.3%
DRUG FACTS BOX OTC-PURPOSE SECTION
Antiseptic
DRUG FACTS BOX OTC-INDICATIONS & USAGE SECTION
for hand-washing to decrease bacteria on the skin
DRUG FACTS BOX OTC-WARNINGS SECTION
For external use only
DRUG FACTS BOX OTC-WHEN USING SECTION
do not get into eyes
if contact occurs, rinse eyes thoroughly with water
DRUG FACTS BOX OTC-STOP USE SECTION
irritation and redness develop
DRUG FACTS BOX OTC-KEEP OUT OF REACH OF CHILDREN SECTION
if swallowed, get medical help or contact a Poison Control Center
right away
DRUG FACTS BOX OTC-DOSAGE & ADMINISTRATION SECTION
wet hands and forearms
apply 5 milliliters (teaspoonful) or palmful to hands and forearms
scrub thoroughly for 1 minute and rinse
DRUG FACTS BOX OTC-INACTIVE INGREDIENT SECTION
water, decyl glucoside, sodium laureth sulfate, cocamide MIPA,
propylene glycol, DMDM
hydantoin, fragrance, methylchloroisothiazolinone,
methylisothiazolinone, aloe
barbadensis, acid red 1
FRESHANDS
FRESHANDS PREMIUM FOAMY ANTIBACTERIAL HANDSOAP 6876
chloroxylenol soap
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:75632-876
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)
CHLOROXYLENOL
3 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ACID RED 1 (UNII: 3365R6427R)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DMDM HYDANTOIN (