Label: PRO-CARE- chloroxylenol soap
- NDC Code(s): 67147-544-06, 67147-544-13, 67147-544-14
- Packager: Apple Products, 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 September 9, 2019
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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
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- Drug Facts Box OTC-Dosage & Administration Section
- Drug Facts Box OTC-Inactive Ingredient Section
- Pro-Care 6890 1 gal
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INGREDIENTS AND APPEARANCE
PRO-CARE
chloroxylenol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67147-544 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) COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) DMDM HYDANTOIN (UNII: BYR0546TOW) ACID RED 1 (UNII: 3365R6427R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67147-544-14 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/09/2019 2 NDC:67147-544-06 1 in 1 BOX 09/09/2019 2 NDC:67147-544-13 800 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/01/2010 Labeler - Apple Products, Inc. (965982544) Registrant - ABC Compounding Co., Inc. (003284353) Establishment Name Address ID/FEI Business Operations ABC Compounding Co., Inc. 003284353 manufacture(67147-544)