Label: LEADER ORIGINAL FORMULA EYE DROPS- tetrahydrozoline hydrochloride solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 11716-4708-8 - Packager: HANLIM PHARM. CO., LTD.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated March 18, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- USER SAFETY WARNINGS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER ORIGINAL FORMULA EYE DROPS
tetrahydrozoline hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11716-4708 Route of Administration OPHTHALMIC DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength BORIC ACID (UNII: R57ZHV85D4) SODIUM CHLORIDE (UNII: 451W47IQ8X) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11716-4708-8 1 in 1 CARTON 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 03/22/2010 Labeler - HANLIM PHARM. CO., LTD. (687986034) Registrant - UNITED EXCHANGE CORP. (840130579) Establishment Name Address ID/FEI Business Operations HANLIM PHARM. CO., LTD. 687986034 manufacture