NDC | 52000-009-01, 52000-009-02, 52000-009-03, 52000-009-04, 52000-009-05, 52000-009-06, 52000-009-07 |
Set ID | 5324154b-ed62-4f1a-99c8-a488ebfccec9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Universal Distribution Center LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333A |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 50 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL SALICYLATE (UNII: LAV5U5022Y) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-009-01 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2012 2 NDC:52000-009-02 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2012 3 NDC:52000-009-03 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2012 4 NDC:52000-009-04 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2012 5 NDC:52000-009-05 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2012 6 NDC:52000-009-06 414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2012 7 NDC:52000-009-07 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/15/2012 Labeler - Universal Distribution Center LLC (019180459) Registrant - Universal Distribution Center LLC (019180459) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-009) Establishment Name Address ID/FEI Business Operations BIOTEK INDIA 675484458 manufacture(52000-009)