PALM- chloroxylenol soap

Palm by

Drug Labeling and Warnings

Palm by is a Otc medication manufactured, distributed, or labeled by 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, citric acid, fragrance, FD and C yellow no.5, food red 10

Palm 6544 Drug Facts and Label

6544 Palm Label

INGREDIENTS AND APPEARANCE

PALM  
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62257-544
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62257-544-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/21/1998
2	NDC: 62257-544-07	700 mL in 1 BAG; Type 0: Not a Combination Product	12/21/1998
3	NDC: 62257-544-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	12/21/1998
4	NDC: 62257-544-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/21/1998
5	NDC: 62257-544-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	12/21/1998
6	NDC: 62257-544-06	1 in 1 BOX	12/21/1998
6	NDC: 62257-544-13	800 mL in 1 BAG; Type 0: Not a Combination Product
7	NDC: 62257-544-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/21/1998
8	NDC: 62257-544-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	12/21/1998
9	NDC: 62257-544-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	12/21/1998
10	NDC: 62257-544-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	12/21/1998

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/21/1998

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

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

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(62257-544)