FM-24 FOAMING- chloroxylenol soap

FM-24 FOAMING by

Drug Labeling and Warnings

FM-24 FOAMING by is a Otc medication manufactured, distributed, or labeled by People's Janitorial Supply, 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, DMDM hydantoin, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, acid red 1

Foamy Mango Antiseptic Hand and Body Wash 6876

Foamy Mango Antiseptic Hand and Body Wash 6876

INGREDIENTS AND APPEARANCE

FM-24 FOAMING 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43097-876
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 (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43097-876-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	11/10/2020
2	NDC: 43097-876-07	700 mL in 1 BAG; Type 0: Not a Combination Product	11/10/2020
3	NDC: 43097-876-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	11/10/2020
4	NDC: 43097-876-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2020
5	NDC: 43097-876-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/10/2020
6	NDC: 43097-876-13	800 mL in 1 BAG; Type 0: Not a Combination Product	11/10/2020
7	NDC: 43097-876-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2020
8	NDC: 43097-876-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2020
9	NDC: 43097-876-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	11/10/2020
10	NDC: 43097-876-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	11/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/10/2020

Labeler - People's Janitorial Supply (057299729)

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

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(43097-876)