FRESHANDS- triclosan soap

FresHands by

Drug Labeling and Warnings

FresHands 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

Triclosan 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, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, alcohol denat., propylene glycol, tetrasodium EDTA, PEG-75 lanolin,  boric acid, lauramine oxide, chloroxylenol, methylparaben, propylparaben, fragrance, aloe barbadensis, acid red 1, reactive green 12

FresHands 6544 18oz

657618P6283.jpg  FresHands  18oz 

INGREDIENTS AND APPEARANCE

FRESHANDS 
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76287-576
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3.0 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
BORIC ACID (UNII: R57ZHV85D4)
ALCOHOL (UNII: 3K9958V90M)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-75 LANOLIN (UNII: 09179OX7TB)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76287-576-06	1 in 1 BOX
1		800 mL in 1 BAG
2	NDC: 76287-576-17	532 mL in 1 BOTTLE, PLASTIC
3	NDC: 76287-576-24	118 mL in 1 BOTTLE, PLASTIC
4	NDC: 76287-576-01	1200 mL in 1 CARTRIDGE
5	NDC: 76287-576-03	350 mL in 1 CARTRIDGE
6	NDC: 76287-576-05	540 mL in 1 BOTTLE, PLASTIC
7	NDC: 76287-576-07	700 mL in 1 BAG
8	NDC: 76287-576-09	2000 mL in 1 CARTRIDGE
9	NDC: 76287-576-10	1000 mL in 1 CARTRIDGE
10	NDC: 76287-576-11	1000 mL in 1 BOTTLE, PLASTIC
11	NDC: 76287-576-12	1000 mL in 1 BAG
12	NDC: 76287-576-13	800 mL in 1 BAG
13	NDC: 76287-576-14	3785 mL in 1 BOTTLE, PLASTIC
14	NDC: 76287-576-15	946 mL in 1 BOTTLE, PLASTIC
15	NDC: 76287-576-28	149 mL in 1 BOTTLE, PLASTIC
16	NDC: 76287-576-27	800 mL in 1 CARTRIDGE
17	NDC: 76287-576-55	208200 mL in 1 DRUM
18	NDC: 76287-576-08	1 in 1 BOX
18		1000 mL in 1 BAG
19	NDC: 76287-576-16	236 mL in 1 BOTTLE, PLASTIC
20	NDC: 76287-576-18	50 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2011

Labeler - Spa Concepts, Inc. (609438671)

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

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture