Label: ULTIMA DET ANTISEPTIC- chloroxylenol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77249-107-01, 77249-107-02, 77249-107-05, 77249-107-45 - Packager: ATLANTIC CARE CHEMICALS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
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 May 21, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- ACTIVE INGREDIENTS
- INACTIVE INGREDIENTS
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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WARNINGS
When using this product: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor: if irritation occurs, please consult a doctor.
Do not use
• In children less than 2 months of age.
• On open skin wounds.
Warning
• For external use only
- Other information
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ULTIMA DET ANTISEPTIC
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77249-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 50 g in 1 L Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) CASTOR OIL (UNII: D5340Y2I9G) WHITE PINE OIL (UNII: HA5CX6676U) LAURYL ALCOHOL (UNII: 178A96NLP2) S-METHYL METHANETHIOSULFONATE (UNII: 0906Z2356U) WATER (UNII: 059QF0KO0R) CARAMEL (UNII: T9D99G2B1R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77249-107-45 5 L in 1 CAN; Type 0: Not a Combination Product 05/15/2020 2 NDC:77249-107-01 0.1 L in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 3 NDC:77249-107-02 0.2 L in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 4 NDC:77249-107-05 0.5 L in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/15/2020 Labeler - ATLANTIC CARE CHEMICALS PRIVATE LIMITED (861499902) Establishment Name Address ID/FEI Business Operations ATLANTIC CARE CHEMICALS PRIVATE LIMITED 861499902 manufacture(77249-107)