FLORENS ANTISEPTIC HANDSOAP- chloroxylenol soap

Florens Antiseptic Handsoap by

Drug Labeling and Warnings

Florens Antiseptic Handsoap by is a Otc medication manufactured, distributed, or labeled by Certus Medical, Inc., ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, sodium chloride, DMDM hydantoin, methylchloroisothiazolinone, methylisothiazolinone, fragrance, FD and C yellow no.5, food red 10

Floren 6739 1000mL

Florens 6739 1000mL label

INGREDIENTS AND APPEARANCE

FLORENS ANTISEPTIC HANDSOAP 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75990-739
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)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 1 (UNII: 3365R6427R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75990-739-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	08/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/24/2022

Labeler - Certus Medical, Inc. (118806847)

Registrant - ABC Compounding Co., Inc. (003284353)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(75990-739)