NDC | 68599-8630-1, 68599-8630-2, 68599-8630-3, 68599-8630-4, 68599-8630-5, 68599-8630-6 |
Set ID | 4777b5f4-1698-08da-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | McKesson Medical-Surgical Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
For external use only.
Do not use or apply • in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic longer than 1 week unless directed by a doctor
Discontinue use if irritation and redness develop
Consult a doctor in case of • deep or puncture wounds • animal bites • serious burns
Stop use and consult a doctor if the condition persists or gets worse
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
For preparation of the skin prior to surgery • clean the affected area • remove swab by stick • apply to the operative site prior to surgery
For use as a first aid antiseptic • clean the affected area • apply a small amount of this product on the area 1 - 3 times daily • May be covered with a sterile bandage • If bandaged, let dry first
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SWAB
povidone-iodine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-8630 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) NONOXYNOL-10 (UNII: K7O76887AP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-8630-3 10 in 1 CASE 01/17/2017 1 NDC:68599-8630-2 50 in 1 BOX 1 NDC:68599-8630-1 1 in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:68599-8630-6 10 in 1 CASE 01/17/2017 2 NDC:68599-8630-5 25 in 1 BOX 2 NDC:68599-8630-4 3 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/17/2017 Labeler - McKesson Medical-Surgical Inc. (023904428) Establishment Name Address ID/FEI Business Operations Jiangsu Province Jianerkang Medical Dressing Co.,Ltd 530968767 manufacture(68599-8630)