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 forearm
apply 5 milliliters (teaspoonful) or palmful to hands and forearm
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

Lynx Antibacterial Hand Soap 6544 1 gallon

product label

Lynx Antibacterial Hand Soap Label

LYNX ANTIBACTERIAL
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62257-160
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)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62257-160-06	1 in 1 BOX	07/14/2006
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC:62257-160-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2006
3	NDC:62257-160-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2006
4	NDC:62257-160-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/14/2006
5	NDC:62257-160-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/14/2006
6	NDC:62257-160-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2006
7	NDC:62257-160-07	700 mL in 1 BAG; Type 0: Not a Combination Product	07/14/2006
8	NDC:62257-160-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/14/2006
9	NDC:62257-160-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/14/2006
10	NDC:62257-160-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2006
11	NDC:62257-160-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	07/14/2006
12	NDC:62257-160-13	800 mL in 1 BAG; Type 0: Not a Combination Product	07/14/2006
13	NDC:62257-160-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2006
14	NDC:62257-160-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2006
15	NDC:62257-160-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2006
16	NDC:62257-160-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/14/2006
17	NDC:62257-160-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	07/14/2006
18	NDC:62257-160-08	1 in 1 BOX	07/14/2006
18		1000 mL in 1 BAG; Type 0: Not a Combination Product
19	NDC:62257-160-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2006
20	NDC:62257-160-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/14/2006
21	NDC:62257-160-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/14/2006
22	NDC:62257-160-20	75600 mL in 1 DRUM; Type 0: Not a Combination Product	07/14/2006
23	NDC:62257-160-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	07/14/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/14/2006

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

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(62257-160)

Lynx Antibacterial Hand Soap 6544 Drug Facts and Label