GOLD AND SUDSY- chloroxylenol soap
Cosgrove Enterprises, 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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Gold & Sudsy 6544 Drug Facts and Label

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, citric acid, DMDM hydantoin, fragrance, FD and C yellow no.5, food red 10

Gold & Sudsy 6544 800ml

product label

Gold and Sudsy 800ml

GOLD AND SUDSY
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52674-544
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52674-544-06	1 in 1 BOX	10/12/2015
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC:52674-544-07	700 mL in 1 BAG; Type 0: Not a Combination Product	10/12/2015
3	NDC:52674-544-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/12/2015
4	NDC:52674-544-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
5	NDC:52674-544-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	10/12/2015
6	NDC:52674-544-13	800 mL in 1 BAG; Type 0: Not a Combination Product	10/12/2015
7	NDC:52674-544-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2015
8	NDC:52674-544-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/12/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/12/2015

Labeler - Cosgrove Enterprises, Inc. (056128473)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(52674-544)