HIGH FIVE ANTISEPTIC HAND AND BODY WASH- chloroxylenol soap

High Five Antiseptic Hand and Body Wash by

Drug Labeling and Warnings

High Five Antiseptic Hand and Body Wash by is a Otc medication manufactured, distributed, or labeled by Jani-Source, LLC, 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, methylisothiazolinoe, fragrance, aloe barbadensis, acid red 1

High Five Antiseptic Hand and Body Wash 6875

High Five Antiseptic Hand and Body Wash

INGREDIENTS AND APPEARANCE

HIGH FIVE ANTISEPTIC HAND AND BODY WASH 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49557-875
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)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ACID RED 1 (UNII: 3365R6427R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49557-875-06	1 in 1 BOX	10/24/2016
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 49557-875-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2016
3	NDC: 49557-875-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2016
4	NDC: 49557-875-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/24/2016
5	NDC: 49557-875-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/24/2016
6	NDC: 49557-875-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2016
7	NDC: 49557-875-07	700 mL in 1 BAG; Type 0: Not a Combination Product	10/24/2016
8	NDC: 49557-875-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/24/2016
9	NDC: 49557-875-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/24/2016
10	NDC: 49557-875-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2016
11	NDC: 49557-875-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	10/24/2016
12	NDC: 49557-875-13	800 mL in 1 BAG; Type 0: Not a Combination Product	10/24/2016
13	NDC: 49557-875-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2016
14	NDC: 49557-875-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2016
15	NDC: 49557-875-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2016
16	NDC: 49557-875-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	10/24/2016
17	NDC: 49557-875-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	10/24/2016
18	NDC: 49557-875-08	1 in 1 BOX	10/24/2016
18		1000 mL in 1 BAG; Type 0: Not a Combination Product
19	NDC: 49557-875-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2016
20	NDC: 49557-875-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/24/2016
21	NDC: 49557-875-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/24/2016
22	NDC: 49557-875-20	75600 mL in 1 DRUM; Type 0: Not a Combination Product	10/24/2016
23	NDC: 49557-875-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	10/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/24/2016

Labeler - Jani-Source, LLC (079224675)

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

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(49557-875)