Label: HARMONY HIGH FOAMING ANTISEPTIC HAND AND BODY WASH- chloroxylenol soap
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NDC Code(s):
68638-876-01,
68638-876-03,
68638-876-05,
68638-876-06, view more68638-876-07, 68638-876-08, 68638-876-09, 68638-876-10, 68638-876-11, 68638-876-12, 68638-876-13, 68638-876-14, 68638-876-15, 68638-876-16, 68638-876-17, 68638-876-18, 68638-876-19, 68638-876-20, 68638-876-24, 68638-876-27, 68638-876-28, 68638-876-35, 68638-876-55
- Packager: Ric Mar Industries, 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 27, 2018
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- Drug Facts Box OTC-Active Ingredient Section
- Drug Facts Box OTC-Purpose Section
- Drug Facts Box OTC-Indications & Usage Section
- 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
- Harmony High Foaming Antiseptic Hand and Body Wash
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INGREDIENTS AND APPEARANCE
HARMONY HIGH FOAMING ANTISEPTIC HAND AND BODY WASH
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68638-876 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:68638-876-06 1 in 1 BOX 02/01/2017 1 800 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:68638-876-17 532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 3 NDC:68638-876-24 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 4 NDC:68638-876-01 1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 02/01/2017 5 NDC:68638-876-03 350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 02/01/2017 6 NDC:68638-876-05 540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 7 NDC:68638-876-07 700 mL in 1 BAG; Type 0: Not a Combination Product 02/01/2017 8 NDC:68638-876-09 2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 02/01/2017 9 NDC:68638-876-10 1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 02/01/2017 10 NDC:68638-876-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 11 NDC:68638-876-12 1000 mL in 1 BAG; Type 0: Not a Combination Product 02/01/2017 12 NDC:68638-876-13 800 mL in 1 BAG; Type 0: Not a Combination Product 02/01/2017 13 NDC:68638-876-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 14 NDC:68638-876-15 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 15 NDC:68638-876-28 149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 16 NDC:68638-876-27 800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product 02/01/2017 17 NDC:68638-876-55 208200 mL in 1 DRUM; Type 0: Not a Combination Product 02/01/2017 18 NDC:68638-876-08 1 in 1 BOX 02/01/2017 18 1000 mL in 1 BAG; Type 0: Not a Combination Product 19 NDC:68638-876-16 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 20 NDC:68638-876-18 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 21 NDC:68638-876-19 18900 mL in 1 CONTAINER; Type 0: Not a Combination Product 02/01/2017 22 NDC:68638-876-20 75600 mL in 1 DRUM; Type 0: Not a Combination Product 02/01/2017 23 NDC:68638-876-35 132500 mL in 1 DRUM; Type 0: Not a Combination Product 02/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/01/2017 Labeler - Ric Mar Industries, Inc. (051919926) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(68638-876)