Label: SANINTA 10% POVIDONE-IODINE- povidone-iodine solution liquid
- NDC Code(s): 81351-004-01, 81351-004-02
- Packager: LL Pharma
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
- Other Information
- Inactive ingredients
- Questions or Comments?
-
Package Label - Principal Display Panel
NDC: 81351-004-01 / 81351-004-02
Product # 004-01 / 004-02
Hold upright
[Tear here and pour]
[Three 4-inch antiseptic swabsticks impregnated with 10% W/V povidone-iodine solution]
[Tear open]
Saninta
Antiseptic Solution
10% w/v Povidone-Iodine [Solution]
[0.75 Fl.ox (22.5 mL)]
Latex cross-through logo
multiple-use cross-through logo
UPC Code
Manufactured by:
LL Pharma Inc.
5789 rue Cypihot, Saint-Laurent, Quebec H4S 1R3
Made in Canada
www.llpharmainc.com
LOT #: XXXX
EXP.: MM/YYYY
-
INGREDIENTS AND APPEARANCE
SANINTA 10% POVIDONE-IODINE
povidone-iodine solution liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81351-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) NONOXYNOL-9 (UNII: 48Q180SH9T) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81351-004-01 3 in 1 POUCH 08/25/2021 1 2.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product 2 NDC:81351-004-02 22.5 mL in 1 PACKET; Type 0: Not a Combination Product 08/25/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 08/25/2021 Labeler - LL Pharma (206925146) Registrant - LL Pharma (206925146) Establishment Name Address ID/FEI Business Operations LL Pharma Inc. 206925146 manufacture(81351-004) , analysis(81351-004) , label(81351-004) , pack(81351-004)