Label: LORIS POVIDONE-IODINE SOLUTION- povidone-iodine liquid
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NDC Code(s):
68356-119-01,
68356-119-02,
68356-119-03,
68356-119-06, view more68356-119-07
- Packager: LernaPharm Loris Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 21, 2023
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Product # 119-XXU NDC: 68356-119-XX
Loris Povidone-Iodine [Solution]
[TEAR OPEN] [Tear here and pour]
[Three 4-inch antiseptic swabsticks impregnated with 10% W/V povidone iodine solution]
[0.75 Fl. oz (22.5 mL)]
Antiseptic Solution
For hospital and professional use only
MANUFACTURED BY
LERNAPHARM (LORIS) INC.
2323 HALPERN, VILLE ST-LAURENT
QUEBEC, CANADA H4S 1S3
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INGREDIENTS AND APPEARANCE
LORIS POVIDONE-IODINE SOLUTION
povidone-iodine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68356-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68356-119-02 22.5 mL in 1 POUCH; Type 0: Not a Combination Product 04/16/2013 2 NDC:68356-119-06 2.6 mL in 1 PACKET; Type 0: Not a Combination Product 07/14/2017 07/20/2022 3 NDC:68356-119-07 2.6 mL in 1 PACKET; Type 0: Not a Combination Product 07/14/2017 07/20/2022 4 NDC:68356-119-01 3 in 1 POUCH 04/16/2013 4 2.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product 5 NDC:68356-119-03 1 in 1 POUCH 07/14/2017 07/20/2022 5 2.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 04/13/2013 Labeler - LernaPharm Loris Inc. (206940905) Establishment Name Address ID/FEI Business Operations LernaPharm Loris Inc. 206940905 manufacture(68356-119) , label(68356-119) , pack(68356-119)