Label: PALM- chloroxylenol soap
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NDC Code(s):
62257-544-06,
62257-544-07,
62257-544-10,
62257-544-11, view more62257-544-12, 62257-544-13, 62257-544-14, 62257-544-17, 62257-544-27, 62257-544-35, 62257-544-55
- Packager: ABC Compounding Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 26, 2018
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- Drug Facts Box OTC-Active Ingredient Section
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- Drug Facts Box OTC-Warnings Section
- Drug Facts Box OTC-When Using Section
- Drug Facts Box OTC-Stop Use Section
- Drug Facts Box OTC-Keep Out of Reach of Children Section
- Drug Facts Box OTC-Dosage & Administration Section
- Drug Facts Box OTC-Inactive Ingredient Section
- Palm 6544 Drug Facts and Label
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INGREDIENTS AND APPEARANCE
PALM
chloroxylenol soapProduct 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)