FRESHANDS INSTANT FOAMING ANTISEPTIC HAND AND BODY WASH- chloroxylenol soap

FresHands Instant Foaming Antiseptic Hand and Body Wash by

Drug Labeling and Warnings

FresHands Instant Foaming Antiseptic Hand and Body Wash by is a Otc medication manufactured, distributed, or labeled by Spa Concepts, 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, DMDM hydantoin, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, acid red 1

FresHands Instant Foaming Antiseptic Hand & Body Wash 6876

FresHands Instant Foaming Hand & Body Wash

INGREDIENTS AND APPEARANCE

FRESHANDS INSTANT FOAMING ANTISEPTIC HAND AND BODY WASH 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76287-876
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76287-876-06	1 in 1 BOX	01/04/2017
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 76287-876-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2017
3	NDC: 76287-876-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2017
4	NDC: 76287-876-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/04/2017
5	NDC: 76287-876-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/04/2017
6	NDC: 76287-876-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2017
7	NDC: 76287-876-07	700 mL in 1 BAG; Type 0: Not a Combination Product	01/04/2017
8	NDC: 76287-876-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/04/2017
9	NDC: 76287-876-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/04/2017
10	NDC: 76287-876-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2017
11	NDC: 76287-876-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/04/2017
12	NDC: 76287-876-13	800 mL in 1 BAG; Type 0: Not a Combination Product	01/04/2017
13	NDC: 76287-876-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2017
14	NDC: 76287-876-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2017
15	NDC: 76287-876-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2017
16	NDC: 76287-876-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/04/2017
17	NDC: 76287-876-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	01/04/2017
18	NDC: 76287-876-08	1 in 1 BOX	01/04/2017
18		1000 mL in 1 BAG; Type 0: Not a Combination Product
19	NDC: 76287-876-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2017
20	NDC: 76287-876-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2017
21	NDC: 76287-876-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/04/2017
22	NDC: 76287-876-20	75600 mL in 1 DRUM; Type 0: Not a Combination Product	01/04/2017
23	NDC: 76287-876-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	01/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/04/2017

Labeler - Spa Concepts, Inc. (609438671)

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

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(76287-876)